A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
Information source: Centocor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: infliximab (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Centocor, Inc. Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.
Summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)
in patients with plaque-type psoriasis.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
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.
Ending date: January 2003
Last updated: March 24, 2008
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