Institutional Review Board, Hospital for Special Surgery
January 13, 2009
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.
A Randomized, Double Blind, Placebo Controlled, Multicenter Prospective Dose Finding Phase II/III Study with Atacicept Given Subcutaneously to Subjects having Recently Experienced a Flare of SLE3.
Inclusion criteria: diagnosis of SLE and active SLE at initial screening, patients older than 16 years of age.
JoAnn Vega
212.774.2795
vegaj@hss.edu
Vidhi Tyagi
212.774.2808
tyagiv@hss.edu
© Hospital for Special Surgery. 535 East 70th Street, New York, NY 10021