Institutional Review Board, Hospital for Special Surgery
December 17, 2010
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.
Stephen J. DiMartino, MD
Horatio Wildman, MD
Funding for this study will be provided by AstraZeneca Pharmaceuticals LP
The main purpose of this study is to evaluate the safety and tolerability of MEDI-570 in subjects with lupus.
Inducible costimulator (ICOS) is a protein that is located on the surface of 5-20% of white blood cells called T-cells. Studies performed in human tissue and in animals show that T-cells with ICOS on the surface may have an important role in lupus, It is hoped that MEDI-570 will reduce the signs and symptoms of lupus by eliminating T-cells that have ICOS on the surface.
About 50 subjects will participate in this study. The study is being performed at approximately 30 sites in Canada, Mexico, South Africa and the United States.
This is a randomized study, which means you will be assigned by chance to receive either MEDI-570 or placebo (a substance that looks like MEDI-570 but does not contain active drug). In this study, there is a 4 out of 5 (80%) chance that you will receive MEDI-570 and 1 out of 5 chance to receive placebo. The medicine will be given by injection under the skin.
Your participation in this study will last at least 6 months and will include at least 12 visits to the study center.
Women who are pregnant or nursing a child may not participate in this study. There may be other reasons why you cannot participate in this research study. Your study doctor or study staff will discuss these with you.
Patients with mildly active lupus will be considered.