Actively Recruiting
Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis
Led by Hospital for Special Surgery, New York · Updated on 2026-02-13
72
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The condition that will be studied is Rheumatoid Arthritis (RA), and in particular, RA patients with moderate to highly active disease who were prescribed Abatacept (Orencia®) (ABA) by their physician during their setting of care at Hospital for Special Surgery (HSS). This investigator-initiated, prospective, comparative, 3-arm observational study will examine changes in lymphocytes in RA patients starting abatacept compared to RA patients starting TNF inhibitors and to healthy controls. This will help investigators to learn more about the processes that cause joints to swell and hurt. This may also offer clues that might predict which patients will have a good or poor response to these treatments.
CONDITIONS
Official Title
Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older with diagnosed Rheumatoid Arthritis
- Patients treated with methotrexate with or without other DMARDs at stable doses for at least 4 weeks, either starting abatacept or remaining on stable treatment possibly including TNF inhibitors
- Diagnosed with RA based on 2010 or 1987 criteria, or treated for RA with typical erosions
- Never treated with abatacept or rituximab; if previously used JAK inhibitors, stopped over a month ago; if used IL-6 inhibitors, stopped over 3 months ago
- Not taking prednisone over 10 mg daily and no recent injectable steroids within 4 weeks before baseline or study assessments
- Evidence of recent or active disease: moderate or high disease activity for abatacept group; stable disease with low activity for TNF inhibitor group; healthy controls free of autoimmune or inflammatory arthritis
- Women of childbearing potential must use acceptable contraception throughout the study
You will not qualify if you...
- Severe RA complications requiring urgent treatment escalation, such as pericarditis or major organ vasculitis
- Presence of other autoimmune or systemic inflammatory rheumatic diseases
- Serious concurrent medical illnesses like terminal cancer
- Body mass index under 18 or over 40
- Previous treatment with rituximab, abatacept, or investigational drugs within 28 days
- Received live vaccines within 2 weeks before study start or planned during study
- Women of childbearing potential with positive pregnancy test or unwilling/unable to use contraception
- Participation in vulnerable populations
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
M
Margaret Butler, BS
CONTACT
C
Caroline Reidy, MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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