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Completed

NCT Number: NCT00794118

Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)

The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Roma, 00161, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eighteen years of age or older
  • Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:
  • Morning stiffness in and around the joints lasting at least 1 hour;
  • Arthritis of 3 or more joint areas;
  • Arthritis of hand joints;
  • Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
  • Rheumatoid nodules;
  • Serum Rheumatoid Factor (RF)
  • Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
  • Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
  • Patients naive to anti-TNF drugs
  • Outpatients

Exclusion criteria

Patients involved in controlled or interventional trials in the 12 previous months

Treatment and study plan

As per clinical practice

Other

As per clinical practice

Other names: Observational study

Primary outcomes

  1. Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3

    Time frame: Month 3

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.

  2. Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6

    Time frame: Month 6

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.

  3. Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9

    Time frame: Month 9

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.

  4. Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12

    Time frame: Month 12

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.

  5. Disease Activity Score Based on 28-joints Count (DAS28) at Month 3

    Time frame: Month 3

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

  6. Disease Activity Score Based on 28-joints Count (DAS28) at Month 6

    Time frame: Month 6

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

  7. Disease Activity Score Based on 28-joints Count (DAS28) at Month 9

    Time frame: Month 9

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

  8. Disease Activity Score Based on 28-joints Count (DAS28) at Month 12

    Time frame: Month 12

    DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

  9. Patient Global Assessment (PtGA) of Disease Activity Score at Month 3

    Time frame: Month 3

    PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.

  10. Patient Global Assessment (PtGA) of Disease Activity Score at Month 6

    Time frame: Month 6

    PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.

  11. Patient Global Assessment (PtGA) of Disease Activity Score at Month 9

    Time frame: Month 9

    PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.

  12. Patient Global Assessment (PtGA) of Disease Activity Score at Month 12

    Time frame: Month 12

    PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.

  13. Physician Global Assessment (PGA) of Disease Activity at Month 3

    Time frame: Month 3

    PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.

  14. Physician Global Assessment (PGA) of Disease Activity at Month 6

    Time frame: Month 6

    PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.

  15. Physician Global Assessment (PGA) of Disease Activity at Month 9

    Time frame: Month 9

    PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.

  16. Physician Global Assessment (PGA) of Disease Activity at Month 12

    Time frame: Month 12

    PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.

  17. Visual Analogue Scale for Pain (VAS-pain) at Month 3

    Time frame: Month 3

    10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.

  18. Visual Analogue Scale for Pain (VAS-pain) at Month 6

    Time frame: Month 6

    10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.

  19. Visual Analogue Scale for Pain (VAS-pain) at Month 9

    Time frame: Month 9

    10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.

  20. Visual Analogue Scale for Pain (VAS-pain) at Month 12

    Time frame: Month 12

    10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.

  21. C-reactive Protein (CRP) at Month 3

    Time frame: Month 3

    CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.

  22. C-reactive Protein (CRP) at Month 6

    Time frame: Month 6

    CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.

  23. C-reactive Protein (CRP) at Month 9

    Time frame: Month 9

    CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.

  24. C-reactive Protein (CRP) at Month 12

    Time frame: Month 12

    CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.

  25. Erythrocyte Sedimentation Rate (ESR) at Month 3

    Time frame: Month 3

    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

  26. Erythrocyte Sedimentation Rate (ESR) at Month 6

    Time frame: Month 6

    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

  27. Erythrocyte Sedimentation Rate (ESR) at Month 9

    Time frame: Month 9

    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

  28. Erythrocyte Sedimentation Rate (ESR) at Month 12

    Time frame: Month 12

    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

  29. Number of Participants With Rheumatoid Factor (RF) at Month 3

    Time frame: Month 3

    RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.

  30. Number of Participants With Rheumatoid Factor (RF) at Month 6

    Time frame: Month 6

    RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.

  31. Number of Participants With Rheumatoid Factor (RF) at Month 9

    Time frame: Month 9

    RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.

  32. Number of Participants With Rheumatoid Factor (RF) at Month 12

    Time frame: Month 12

    RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.

  33. Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3

    Time frame: Month 3

    Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.

  34. Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6

    Time frame: Month 6

    Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.

  35. Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9

    Time frame: Month 9

    Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.

  36. Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12

    Time frame: Month 12

    Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.

  37. Number of Participants With Anti-nuclear Antibodies at Month 3

    Time frame: Month 3

    Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.

  38. Number of Participants With Anti-nuclear Antibodies at Month 6

    Time frame: Month 6

    Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.

  39. Number of Participants With Anti-nuclear Antibodies at Month 9

    Time frame: Month 9

    Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.

  40. Number of Participants With Anti-nuclear Antibodies at Month 12

    Time frame: Month 12

    Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.

  41. Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3

    Time frame: Month 3

    Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.

  42. Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6

    Time frame: Month 6

    Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.

  43. Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9

    Time frame: Month 9

    Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.

  44. Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12

    Time frame: Month 12

    Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.

  45. Duration of Morning Stiffness at Month 3

    Time frame: Month 3

    Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

  46. Duration of Morning Stiffness at Month 6

    Time frame: Month 6

    Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

  47. Duration of Morning Stiffness at Month 9

    Time frame: Month 9

    Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

  48. Duration of Morning Stiffness at Month 12

    Time frame: Month 12

    Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

  49. Stanford Health Assessment Questionnaire (HAQ) Score at Month 3

    Time frame: Month 3

    HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).

  50. Stanford Health Assessment Questionnaire (HAQ) Score at Month 6

    Time frame: Month 6

    HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).

  51. Stanford Health Assessment Questionnaire (HAQ) Score at Month 9

    Time frame: Month 9

    HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).

  52. Stanford Health Assessment Questionnaire (HAQ) Score at Month 12

    Time frame: Month 12

    HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).

  53. 36-Item Short-Form Health Survey (SF-36) at Month 12

    Time frame: Month 12

    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Secondary outcomes

  1. Direct Costs

    Time frame: Baseline, Months 3, 6, 9 and 12

    Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.

  2. Indirect Costs

    Time frame: Baseline, Months 3, 6, 9 and 12

    Indirect costs represent the loss of resources as a consequence of work disability or unemployment.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study

Acronym: DOSE

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 19, 2008
Registry last updated
Jul 1, 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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