May 17, 2006
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
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.
JoAnn Vega
212.774.2795
vegaj@hss.edu