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

Centocor, Inc.249 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

249

Conditions

Psoriasis

Interventions

infliximabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10

Secondary Outcomes

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

Data from ClinicalTrials.gov

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