A Safety and Efficacy Study 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.

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