A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis
The purpose of this study is to determine if infliximab (anti-TNF) is effective in the treatment of plaque psoriasis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction and Maintenance Therapy in Patients With Moderate to Severe Plaque Psoriasis|
- Proportion of patients achieving a = 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline at week 10
- The patients with = 75% improvement in PASI score from baseline to week 24 ,Change in Dermatology Life Quality Index from baseline to week 10 and week 24 , patients achieving a Physician Global Assessment score of cleared (0) or minimal(1) at week 10
|Study Completion Date:||October 2004|
This is an experimental medical research study. The purpose of this study is to determine if infliximab is effective in the treatment of plaque psoriasis. A total of about 375 patients primarily in Europe will participate in this study. The time of participation in this study is about 17 months. Infliximab is the active drug in Remicade. Infliximab is currently approved for the treatment of Crohn's disease (an irritable bowel disease), and rheumatoid arthritis. The usefulness and safety of infliximab in those diseases has been proven in previous research studies, which included more than 1300 patients in North America and Europe. 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.
Patients will be assigned to one of two treatment groups (Group 1 and Group 2). Group 1 will receive 5mg/kg infliximab infusions at wks 0, 2, 4, 6, 14, 22, 30, 38 and 46 with placebo infusions at wks 24 and 26. Group 2 will receive placebo infusions at wks 0, 2, 6, 10, 14, 22, with placebo infusions at wks 24, 26, 30, 38 and 46. All study medication is given though an intravenous (into the vein) line.
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. There are 2 different treatment groups: Group 1 will receive 5mg/kg infliximab infusions at wks 0, 2, 4, 6, 14, 22, 30, 38 and 46 with placebo infusions at wks 24 and 26. Group 2 will receive placebo infusions at wks 0, 2, 6, 10, 14, 22, with placebo infusions at wks 24, 26, 30, 38 and 46. All study medication is given though an intravenous (into the vein) line.