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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00779675 |
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.
Condition | Intervention |
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Psoriasis |
Biological: Infliximab |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis |
Estimated Enrollment: | 1000 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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.
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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.
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The population in this study was chosen using a non-probability sampling method.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
A subject with psoriasis whom the physician has chosen to treat with infliximab in accordance with local clinical practices will be advised about this trial.
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.
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Canada | |
Investigational Site 9 | Recruiting |
Quebec, Canada, G17 1X7 | |
Investigational Site 16 | Recruiting |
St. John's, Canada, A1B 3E1 | |
Investigational Site 10 | Recruiting |
Montreal, Canada, H3Z 2S6 | |
Investigational Site 12 | Recruiting |
St. John's, Canada, A1B 4S8 | |
Investigational Site 23 | Recruiting |
Oakville, Canada, L6J 7W5 | |
Investigational Site 20 | Recruiting |
Montreal, Canada, H2K 4L5 | |
Investigational Site 22 | Recruiting |
Quebec, Canada, G1V 4X7 | |
Investigational Site 19 | Recruiting |
Markham, Canada, L3P 1A8 | |
Investigational Site 25 | Recruiting |
Windsor, Canada, N8W 5L7 | |
Investigational Site 26 | Recruiting |
St. John's, Canada, A1B 4S8 | |
Investigational Site 8 | Recruiting |
Niagara Falls, Canada, L2R 2E4 | |
Investigational Site 13 | Recruiting |
London, Canada, N5X 2P1 | |
Investigational Site 17 | Recruiting |
Mississauga, Canada, L4Y 1A6 | |
Denmark | |
Investigational Site 55 | Recruiting |
Copenhagen, Denmark, 2450 NV | |
Investigational Site 57 | Recruiting |
Aarhus, Denmark, 8000 C | |
Hungary | |
Investigational Site 94 | Recruiting |
Debrecen, Hungary, 4012 | |
Netherlands | |
Investigational Site 1 | Recruiting |
Alkmaar, Netherlands, 1815 KX |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05319 |
Study First Received: | October 23, 2008 |
Last Updated: | August 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00779675 History of Changes |
Health Authority: | Canada: Health Canada |
Anti-Inflammatory Agents Skin Diseases Infliximab |
Psoriasis Antirheumatic Agents Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Skin Diseases Infliximab Psoriasis Therapeutic Uses |
Gastrointestinal Agents Antirheumatic Agents Dermatologic Agents Skin Diseases, Papulosquamous Pharmacologic Actions |