February 14, 2012
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.
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
http://www.illuminatestudies.com/
Inclusion criteria:
18 years or older
Clinical diagnosis of lupus (SLE)
Active disease
Exclusion criteria:
Lupus kidney disease
Taking more than 40 mg of oral corticosteroids every day
JoAnn Vega, CCRC
vegaj@hss.edu
212.774.2795