Institutional Review Board, Hospital for Special Surgery
May 17, 2006
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
The purpose of this study is to assess the efficacy of rituximab compared with placebo for the treatment of patients with active systemic lupus erythematosus (SLE). This is a multi-center trial in which patients will be followed for 18 months.
Patient must have active SLE despite treatment at the time of enrollment.