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Completed

NCT Number: NCT01387815

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Skin Advancement /ID# 66782, Calgary, Alberta, Canada

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About this study

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active moderate or severe plaque psoriasis according to the judgment of the treating physician.
  • The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.

Exclusion criteria

  • Had currently participated in another prospective study with similar objectives.
  • Participant could not or would not sign informed consent.
  • Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.

Treatment and study plan

Adalimumab

Biological

Adalimumab administered by subcutaneous injection.

Other names: Humira

Primary outcomes

  1. Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6

    Time frame: Month 6

    The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
    • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
    • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
    • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
    • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
    • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

    A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit.

Secondary outcomes

  1. Time to Achieving PGA ≤ 1

    Time frame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24

    The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
    • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
    • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
    • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
    • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
    • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

    A higher score indicates greater disease severity.

  2. PGA≤1: Percentage of Participants at Month 3

    Time frame: Month 3

    The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
    • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
    • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
    • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
    • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
    • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

    A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

  3. PGA≤1: Percentage of Participants at Month 12

    Time frame: Month 12

    The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
    • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
    • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
    • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
    • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
    • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

    A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

  4. PGA≤1: Percentage of Participants at Month 18

    Time frame: Month 18

    The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
    • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
    • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
    • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
    • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
    • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

    A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

  5. PGA≤1: Percentage of Participants at Month 24

    Time frame: Month 24

    The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
    • 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
    • 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
    • 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
    • 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
    • 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

    A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

  6. Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3

    Time frame: Baseline, Month 3

    PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

  7. PASQ Total Score: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

  8. PASQ Total Score: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

  9. PASQ Total Score: Change From Baseline to Month 18

    Time frame: Baseline, Month 18

    PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

  10. PASQ Total Score: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

  11. Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    The Body Surface Area (BSA) is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

  12. BSA of Psoriasis Involvement: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

  13. BSA of Psoriasis Involvement: Change From Baseline to Month 18

    Time frame: Baseline, Month 18

    The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

  14. BSA of Psoriasis Involvement: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

  15. Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3

    Time frame: Baseline, Month 3

    Patient Global Assessment of disease activity (PtGA) was assessed using a visual analog scale (VAS) where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

  16. PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

  17. PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

  18. PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18

    Time frame: Baseline, Month 18

    PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

  19. PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

  20. Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3

    Time frame: Baseline, Month 3

    The Dermatology Quality of Life Index (DLQI) is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

  21. DLQI Total Score: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

  22. DLQI Total Score: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

  23. DLQI Total Score: Change From Baseline to Month 18

    Time frame: Baseline, Month 18

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

  24. DLQI Total Score: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

  25. Time to Achieving DLQI ≤1

    Time frame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

  26. DLQI ≤1: Percentage of Participants at Month 3

    Time frame: Month 3

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

  27. DLQI ≤1: Percentage of Participants at Month 6

    Time frame: Month 6

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

  28. DLQI ≤1: Percentage of Participants at Month 12

    Time frame: Month 12

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

  29. DLQI ≤1: Percentage of Participants at Month 18

    Time frame: Month 18

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

  30. DLQI ≤1: Percentage of Participants at Month 24

    Time frame: Month 24

    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

  31. Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

    The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

    The higher the score, the greater the severity of the depression.

  32. BDI-II: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

    The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

    The higher the score, the greater the severity of the depression.

  33. BDI-II: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

    The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

    The higher the score, the greater the severity of the depression.

  34. Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    The Medical Outcomes Study Short Form 12 (SF-12) questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.

  35. SF-12 MCS Score: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.

  36. SF-12 MCS Score: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.

  37. SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.

  38. SF-12 PCS Score: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.

  39. SF-12 PCS Score: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.

  40. Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    The Work Limitation Questionnaire (WLQ) is a self-administered questionnaire comprised of 25 questions.

    The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

    The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

  41. WLQ Total Score: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

    The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

  42. WLQ Total Score: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

    The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

  43. WLQ Productivity Loss Score: Change From Baseline to Month 6

    Time frame: Baseline, Month 6

    The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

    The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

  44. WLQ Productivity Loss Score: Change From Baseline to Month 12

    Time frame: Baseline, Month 12

    The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

    The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

  45. WLQ Productivity Loss Score: Change From Baseline to Month 24

    Time frame: Baseline, Month 24

    The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

    The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

  46. Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  47. HCRU: Number of Participants With Insurance for Prescription Medication at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  48. HCRU: Number of Participants With Insurance for Prescription Medication at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  49. HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  50. HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  51. HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  52. HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  53. HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  54. HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  55. HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  56. HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  57. HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  58. HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  59. HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  60. HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  61. HCRU: Number of Participants Making Visits to Another Physician at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  62. HCRU: Number of Participants Making Visits to Another Physician at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  63. HCRU: Number of Participants Making Visits to Another Physician at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  64. HCRU: Number of Visits to Another Physician at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  65. HCRU: Number of Visits to Another Physician at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  66. HCRU: Number of Visits to Another Physician at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  67. HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  68. HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  69. HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  70. HCRU: Number of Visits to A Healthcare Professional at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  71. HCRU: Number of Visits to A Healthcare Professional at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  72. HCRU: Number of Visits to A Healthcare Professional at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  73. HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  74. HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  75. HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  76. HCRU: Number of Visits to a Hospital Emergency Room at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  77. HCRU: Number of Visits to a Hospital Emergency Room at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  78. HCRU: Number of Visits to a Hospital Emergency Room at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  79. HCRU: Number of Participants Making Use of an Ambulance Service at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  80. HCRU: Number of Participants Making Use of an Ambulance Service at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  81. HCRU: Number of Participants Making Use of an Ambulance Service at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  82. HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  83. HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  84. HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  85. HCRU: Number of Complementary/Alternate Therapy Visits at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  86. HCRU: Number of Complementary/Alternate Therapy Visits at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  87. HCRU: Number of Complementary/Alternate Therapy Visits at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  88. HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  89. HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  90. HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  91. HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  92. HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  93. HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  94. HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  95. HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  96. HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  97. HCRU: Cost of Payment for Over the Counter Medications at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  98. HCRU: Cost of Payment for Over the Counter Medications at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  99. HCRU: Cost of Payment for Over the Counter Medications at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  100. HCRU: Cost of Payments to Healthcare Professionals at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  101. HCRU: Cost of Payments to Healthcare Professionals at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  102. HCRU: Cost of Payments to Healthcare Professionals at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  103. HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  104. HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  105. HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  106. HCRU: Cost of Payments for Medical Devices at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  107. HCRU: Cost of Payments for Medical Devices at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  108. HCRU: Cost of Payments for Medical Devices at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  109. HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  110. HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  111. HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  112. HCRU: Cost of Payments for Transportation at Month 6

    Time frame: Month 6

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  113. HCRU: Cost of Payments for Transportation at Month 12

    Time frame: Month 12

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  114. HCRU: Cost of Payments for Transportation at Month 24

    Time frame: Month 24

    Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

  115. Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3

    Time frame: Month 3

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  116. Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6

    Time frame: Month 6

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  117. Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12

    Time frame: Month 12

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  118. Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18

    Time frame: Month 18

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  119. Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24

    Time frame: Month 24

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  120. Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3

    Time frame: Month 3

    Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

  121. Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6

    Time frame: Month 6

    Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

  122. Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12

    Time frame: Month 12

    Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

  123. Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18

    Time frame: Month 18

    Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

  124. Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24

    Time frame: Month 24

    Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

  125. Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3

    Time frame: Month 3

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  126. Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6

    Time frame: Month 6

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  127. Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12

    Time frame: Month 12

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  128. Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18

    Time frame: Month 18

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  129. Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24

    Time frame: Month 24

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  130. Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3

    Time frame: Month 3

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  131. Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6

    Time frame: Month 6

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  132. Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12

    Time frame: Month 12

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  133. Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18

    Time frame: Month 18

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  134. Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24

    Time frame: Month 24

    Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

  135. Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3

    Time frame: Month 3

    Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

  136. Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6

    Time frame: Month 6

    Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

  137. Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12

    Time frame: Month 12

    Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

  138. Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18

    Time frame: Month 18

    Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

  139. Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24

    Time frame: Month 24

    Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

  140. Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3

    Time frame: Month 3

    Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

  141. Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6

    Time frame: Month 6

    Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

  142. Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12

    Time frame: Month 12

    Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

  143. Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18

    Time frame: Month 18

    Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

  144. Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24

    Time frame: Month 24

    Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

  • Cato Research
  • JSS Medical Research Inc.

Registry information

Acronym: Complete-PS

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2011
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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