A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2003-01-31

Brief Summary

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The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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infliximab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No