Institutional Review Board, Hospital for Special Surgery
November 17, 2022
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.
Vivian P. Bykerk, BSc, MD, FRCPC
Amit Lakhanpal, MD, PhD
Melanie Smith, MD, PhD
Laura Donlin, PhD
This is a single site, mechanistic study examining changes in lymphocytes in Rheumatoid Arthritis (RA) patients starting abatacept compared to RA patients starting TNF inhibitors and to healthy controls. This will help us to learn more about the processes that cause joints to swell and hurt. This may also give us clues that might predict which patients will have a good or poor response to these treatments.
72 participants will be enrolled into three separate arms:
All participants will have 3 study visits over 6 months including a blood draw and questionnaires related to functioning and feeling with RA, where applicable. Participants will be compensated $75 per visit.
Inclusion Criteria include:
Exclusion Criteria include:
Margaret Butler, Research Coordinator