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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00230529 |
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.
Condition | Intervention | Phase |
---|---|---|
Psoriasis |
Drug: infliximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE®) Induction Therapy in Patients With Plaque-Type Psoriasis |
Estimated Enrollment: | 200 |
Study Completion Date: | January 2003 |
The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement.
The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003124 |
Study First Received: | September 29, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00230529 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Plaque-type Psoriasis Remicade infliximab biologics |
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 |