Institutional Review Board, Hospital for Special Surgery
April 15, 2019
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.
This is a multi-center, prospective, observational cohort study to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in patients with active, autoantibody-positive SLE treated with and without BENLYSTA.
• The study will enroll approximately 3,000 patients, approximately 2,000 in the
BENLYSTA cohort and 1,000 in the comparison cohort.
• Enrollment has been extended to January 2020
• Data will be collected at enrollment and at 6 month intervals for 5 years (60 months).
JoAnn Vega, CCRC