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Research

Immune System Regulation in Autoimmune and Inflammatory Diseases

IRB Number: 2014-221

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.

Principal Investigator

Mary K. Crow, MD

Co-Investigators

Kyriakos A. Kirou, MD, DSc, FACP
David R. Fernandez, MD, PhD
Mikhail Olferiev
Mary Peng

Summary

The purpose of this study is to gain new understandings of autoimmune and inflammatory diseases, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, myositis, osteoarthritis, and others.

Researchers at the Hospital for Special Surgery would like to obtain samples of blood and/or urine from individuals that are affected by these diseases, along with information about the features of your disease. We are particularly interested in collecting blood samples over time, during the course of your disease. We will perform analysis of your blood or urine samples to characterize the molecules and cells of your immune system and other molecules and cells that interact with the immune system. The samples collected will also be compared to individuals who are not affected by these diseases and will be analyzed in relation to your disease activity, organ involvement and blood tests. By comparing samples from those affected and those not affected by these diseases, we can evaluate mechanisms of autoimmune diseases and determine new targets for therapeutic intervention.

Study participation is voluntary. If consented into this study, we will draw 1-5 tube(s) of blood from a vein in your arm at each of your doctor visits, for up to a total of 8 visits.

Inclusion/Exclusion Criteria

Inclusion/Exclusion Criteria:

  • Must be 13 years of age or older
  • Must have a history or diagnosis of an autoimmune or inflammatory disease or be willing to serve as a healthy volunteer
  • Must be willing to donate up to 20 mL of blood (about 4 teaspoons) per visit
  • Must be willing to complete and sign an Informed Consent Form upon agreeing to be in the study
  • Must be a patient at the Hospital for Special Surgery or a healthy volunteer
  • We will also be collecting information from you using a short questionnaire to aid us in our research

Contact Information

Mary Peng
Research Coordinator
pengm@hss.edu
212.774.2967