A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis
The purpose of this study is to determine if Infliximab is safe and effective in the treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-blind Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Patients With Psoriatic Arthritis|
- The proportion of patients with American College of Rheumatology (ACR) 20 response at week 14 Change from baseline in total radiographic scores of hands and feet at week 24
- Number of patients who achieved an ACR 20 response at wk 24; PsARC at wk 14; proportion of patients with >= to 75% Improvement From Baseline in PASI at Week 14; change from baseline SF 36 physical component summary scores at wk 14
|Study Start Date:||May 2003|
|Study Completion Date:||June 2004|
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 study designed to determine the safety and effectiveness of Infliximab in the treatment of patients with psoriatic arthritis. This is an experimental medical research study. A total of 200 people in North America and Europe participated in this study during the 17 month study period. Patients will receive infusions of either placebo or 5 or 10 mg/kg infliximab (Remicade) at weeks 0,2, 6, 14, 16, 18, 22, 30, 38, and 46. 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 either placebo or 5 mg/kg induction infusions (weeks 0, 2 and 6) followed by maintenance infusions every 8 weeks until week 46. In the placebo group, patients may early escape at week 16 and crossover at week 24 to infliximab;. In the 5mg/kg group, dose escalation if needed at week 38.