Psoriasis Clinical Trial
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
The purpose of this study is to determine if infliximab (anti-TNF) is effective in the treatment of plaque psoriasis.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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