IRB Number: 2021-0142
Institutional Review Board, Hospital for Special Surgery
November 17, 2022
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S. Louis Bridges, Jr. MD, PhD
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:
- Arm 1: Patients beginning abatacept as a treatment for their RA
- Arm 2: Patients beginning a TNF inhibitor as a treatment for their RA
- Arm 3: Healthy volunteers (free from autoimmune or connective tissue disease)
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:
- male or female ≥ 18 y.o.
- able to adhere to study schedule and comply with other study requirements
- willing to sign Informed Consent and consent to genetic testing.
- diagnosed with RA with moderate disease activity and being treated with methotrexate at stable doses for at least 4 weeks who are either
- about to start abatacept (first or subsequent biologic; Arm 1), or
- who are likely to remain on stable DMARDs, and who are starting a TNFi (Arm 2)
- have not received ABA within 9 months or a TNFi within 6 month of study entry
- Healthy Control must be free of any autoimmune disease or systemic form of inflammatory arthritis.
Exclusion Criteria include:
- Individuals experiencing severe complications of RA that might require imminent escalation of therapy, e.g. pericarditis, active vasculitis of a major organ system
- Have an autoimmune disease or systemic inflammatory rheumatic disease (e.g., lupus erythematosus) that could confound T and B cell subset results.
- Have received the following Prohibited Treatments and/or Therapies:
- treatment with rituximab
- exposed to any investigational drug within 28 days.
- Received any live vaccines within 2 weeks prior to study start.
- Are unwilling to continue the treatment prescribed for them for reasons unrelated to the disease.
Margaret Butler, Research Coordinator