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Sponsors and Collaborators: |
Schering-Plough Centocor, Inc. |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00686686 |
Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at Week 18. Subjects whose deterioration of Psoriasis Severity Index (PASI) score is >50% from week 8 until week 12 compared to baseline score will be eligible for an additional infusion at Week 12 and will be followed up at Week 18.
Condition | Intervention | Phase |
---|---|---|
Psoriasis |
Biological: Infliximab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Multi Center, Open Label, Single-Arm Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP), Including the Pustular Form (PsPPP) |
Estimated Enrollment: | 32 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Infliximab 5 mg/kg: Experimental
Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and optional at week 12.
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Biological: Infliximab
Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and optional at week 12.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Israel | |
Investigational Site 15 | Recruiting |
Petach Tikva, Israel | |
Investigational Site 2 | Recruiting |
Ramat Gan, Israel | |
Investigational Site 3 | Recruiting |
Jerusalem, Israel | |
Investigational Site 4 | Recruiting |
Afula, Israel | |
Investigational Site 1 | Recruiting |
Petach Tikva, Israel |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04555 |
Study First Received: | May 27, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00686686 |
Health Authority: | Israel: Ministry of Health; Israel: Ethics Commission |
Skin Diseases Infliximab Psoriasis Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |