Assessment of Long-Term Infliximab for Psoriasis (P05319 AM1) (REALITY)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00779675
First received: October 23, 2008
Last updated: November 16, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Psoriasis |
Biological: Infliximab |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50 [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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 Outcome Measures:
- Participant PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14 [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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 a greater than 90% improvement when compared to baseline.
- Participant PASI-90 and PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14 [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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.
- Participant PASI-90, PASI-75, and PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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.
- Participant 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 ] [ Designated as safety issue: No ]
- Participant PASI-90, PASI-75, 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 ] [ Designated as safety issue: No ]
- Participant Absolute PASI Score and Change From Baseline in Absolute PASI Score [ Time Frame: Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98 ] [ Designated as safety issue: No ]
- PASI-90 and 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 ] [ Designated as safety issue: No ]
- Participant Dermatology Life Quality Index (DLQI) Response [ Time Frame: Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98 ] [ Designated as safety issue: No ]
- Participant DLQI Raw Score [ Time Frame: Week 14, Week 30, Week 50, Week 62, Week 78, Week 98 ] [ Designated as safety issue: No ]
- Participants With a PASI-50, PASI-75, PASI-90, and PASI-100 Response [ Time Frame: Week 98 ] [ Designated as safety issue: No ]
- Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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.
- Number of Participants Who Achieved a PASI-75 Response AT Week 50 by Gender [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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.
- Number of Participants Who Achieved a PASI-75 Response AT Week 50 by Race [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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.
- Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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.
- Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline [ Time Frame: Week 50 ] [ Designated as safety issue: No ]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..
| Enrollment: | 660 |
| Study Start Date: | October 2008 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Infliximab 5 mg/kg |
Biological: Infliximab
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:
|
Detailed Description:
This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants with plaque-type psoriasis in which the treating physician has selected for treatment with infliximab, in accordance with local clinical practices, will be advised about this trial. It is highly recommended that 30% of the participants enrolled be naïve to previous biologic therapy. For example, if a site recruits 10 participants, 3 out of these 10 participants should be naïve to previous biologic therapy.
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00779675 History of Changes |
| Other Study ID Numbers: | P05319 |
| Study First Received: | October 23, 2008 |
| Results First Received: | September 27, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Infliximab Dermatologic Agents |
Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013