Tracking Information
Start Date ICMJE | October 2008 |
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Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: October 23, 2008) | The proportion of subjects with a PASI-75 response (change in PASI of >=75% from Baseline) at Week 50. [ Time Frame: Week 50 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00779675 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 23, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Assessment of Long-Term Infliximab for Psoriasis (Study P05319) |
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Official Title ICMJE | Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis |
Brief Summary | This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in subjects 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. |
Detailed Description | The population in this study was chosen using a non-probability sampling method. |
Study Phase | |
Study Type ICMJE | Observational |
Study Design ICMJE | Cohort, Prospective |
Condition ICMJE | Psoriasis |
Intervention ICMJE | Biological: Infliximab 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 PM for Canada, the approved SPC for countries in the EU, or per label according to local guidelines for all other participating countries. Other Names:
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Study Arms / Comparison Groups | Remicade The studied population will be comprised of subjects with a physician's diagnosis of plaque-type psoriasis. It is highly recommended that 30% of the subjects enrolled be naïve to previous biologic therapy. For example, if a site recruits 10 subjects, 3 out of these 10 subjects should be naïve to previous biologic therapy. Intervention: Biological: Infliximab |
Recruitment Information
Estimated Enrollment ICMJE | 1000 | ||||
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Estimated Completion Date | June 2011 | ||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a subject so long as the subject 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. | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Canada, Denmark, Germany, Hungary, Netherlands, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00779675 |
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Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
Study ID Numbers ICMJE | P05319 |
Study Sponsor ICMJE | Schering-Plough |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Schering-Plough |