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Completed

NCT Number: NCT00779675

Assessment of Long-Term Infliximab for Psoriasis (P05319)

This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant must have a diagnosis of plaque-type psoriasis
  • Participant's physician must have decided, with the subject's consent, to start treatment with infliximab
  • Participant must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent
  • For inclusion into the extended treatment period, participant must have completed 50 weeks of infliximab treatment in the treatment period
  • For inclusion into the extended treatment period, participant must be continuing treatment with intravenous infliximab
  • For inclusion into the extended treatment period, participant must have an improvement in their PASI score of greater than or equal to 25% at the time of entry into to the extended treatment period

Exclusion criteria

For the Treatment Period

  • Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is eligible for the trial (Inclusion Criteria). The treating physician is expected, as in normal clinical practice, to follow the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications and precautions

For the Extended Treatment Period

  • Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is receiving infliximab treatment in accordance with the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications, precautions, dosing and frequency of administration

Treatment and study plan

Infliximab

Biological

Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).

Other names: Remicade, SCH 215596

Primary outcomes

  1. Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50

    Time frame: Week 50

    Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.

Secondary outcomes

  1. Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14

    Time frame: Week 50

    Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline.

  2. Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14

    Time frame: Week 50

    Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline.

  3. Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14

    Time frame: Week 50

    Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline.

  4. Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period

    Time frame: Week 98

    Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline.

  5. Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period

    Time frame: Week 98

    Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively.

  6. Change From Baseline in Mean PASI Score

    Time frame: Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98

    Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.

  7. Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase

    Time frame: Week 98

    PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively.

  8. Change From Baseline in Mean Dermatology Life Quality Index (DLQI)

    Time frame: Baseline, Week 50, Week 62, Week 78, Week 98

    The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.

  9. Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase

    Time frame: Week 50, Week 62, Week 78, Week 98

    The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.

  10. Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98

    Time frame: Week 98

    Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively.

  11. Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age

    Time frame: Week 50

    Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.

  12. Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender

    Time frame: Week 50

    Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.

  13. Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race

    Time frame: Week 50

    Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.

  14. Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline

    Time frame: Week 50

    Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.

  15. Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline

    Time frame: Week 50

    Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline..

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis

Acronym: REALITY

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Oct 24, 2008
Registry last updated
Nov 2, 2015

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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