Psoriasis Clinical Trial
Official title:
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance InfliximabTherapy in Patients With Plaque-Type Psoriasis
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.
This is a phase III, multicenter, randomized (patients are assigned different treatments
based on chance), double-blind (neither the patient nor the physician knows whether drug or
placebo is being taken, or at what dosage), placebo-controlled trial evaluating the
effectiveness and safety of scheduled and as needed treatment with infliximab in patients
with plaque-type psoriasis. This study will also help determine the way to use infliximab in
treating patients with psoriasis.
Safety evaluations will be performed at specified intervals throughout the study and will
consist of laboratory tests, vital signs (such as blood pressure), physical examinations and
the occurrence and severity of adverse events as well as other study specific procedures.
Patients will receive infusions of either placebo, 3mg/kg or 5 mg/kg infliximab (Remicade)
at weeks 0, 2, 6 14, 18, 22, 26, 30, 34, 38, 42 and 46. Patients receive either 3mg/kg, 5
mg/kg or placebo infusions at week 0, 2, and 6. The 3mg/kg and 5 mg/kg infliximab groups
then receive either every 8 week infusions or infusions as needed when their psoriasis is
less than 75% improved from baseline. The placebo patients begin infliximab at week 16, 18
and 22 followed by every 8 week infusions.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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