A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
Phase 2
Completed
- Conditions
- Psoriasis
- Registration Number
- NCT00230529
- Lead Sponsor
- Centocor, Inc.
- Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
Inclusion Criteria
- Must be 18 years of age or older at time of enrollment
- may be male or female
- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
- Have plaque-type psoriasis covering at least 10% of total BSA at baseline
- Have previously received PUVA and/or other systemic treatment for psoriasis
Exclusion Criteria
- Have non-plaque forms of psoriasis
- Have a history of drug-induced psoriasis
- Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
- Have had any previous treatment with infliximab or any therapeutic agent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
- Secondary Outcome Measures
Name Time Method The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week 26 by antibodies to infliximab status at week 26