Institutional Review Board, Hospital for Special Surgery
March 20, 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.
Yurii Chinenov, PhD
Danny Flores Castro
Kyriakos A. Kirou, MD DSc, FACP
Tania Pannellini, MD, PhD
Jane Salmon, MD
Lisa R. Sammaritano, MD
We plan to recruit up to 235 SLE patients who will complete the PROMIS surveys and donate up to 50ml (~3 and ½ tablespoons) of blood at each of their regularly scheduled Rheumatology appointments for the maximum of 8 visits over 2-3 years. Some non-SLE controls will also be recruited and asked to donate up to 50ml (~3 and ½ tablespoons of blood).
SLE patients must be able and willing to provide written informed consent, age 18-65 years, and meet ACR Criteria for SLE. These patients must not have been diagnosed with diabetes mellitus, have a history of active infection, have had recent pulse glucocorticoid therapy (within 1 month), recent cyclophosphamide therapy (within 3 months), Rituximab (within 1 year), anti-TNF agents (within 3 months). Healthy controls must be able and willing to provide written and informed consent, age 18-65 years, have no diagnosis of SLE or another autoimmune disease.