Institutional Review Board, Hospital for Special Surgery
February 14, 2012
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.
Up to 1140 subjects will be taking part in this study internationally. Approximately 4 -5 subjects from Hospital for Special Surgery will participate in the study. Patients will be randomly assigned and will be placed into one of the following three groups:
Group 1: Patient will receive alternating doses of study drug AND placebo every two weeks.
Group 2: Patient will receive ONLY study drug every 2 weeks.
Group3: Patient will receive ONLY placebo every 2 weeks.
Study participation is voluntary and is expected to last up to 2 years for a total of 104 weeks that includes:
• 4 week screening period
• 52 week treatment period
• 48 week follow-up period
18 years or older
Clinical diagnosis of lupus (SLE)
Lupus kidney disease
Taking more than 40 mg of oral corticosteroids every day
JoAnn Vega, CCRC