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Studies of Immune Deregulation in Patients with SLE

IRB Number: 2014-299

March 20, 2019

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.

Principal Investigator

Alessandra Pernis, MD


Yurii Chinenov, PhD
 Zhu Chen
Danny Flores Castro
Sanjay Gupta
Kyriakos A. Kirou, MD DSc, FACP
Michela Manni
Tania Pannellini, MD, PhD
Mary Peng
Edd Ricker
Cristina Rozo
Jane Salmon, MD
Lisa R. Sammaritano, MD
Joann Vega
Haley Slosberg


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).

Inclusion/Exclusion Criteria

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.

Contact Information

Haley Slosberg, Research Coordinator