Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT05782335
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)

Arms

  • Arm: Arm 1: Abatacept Initiator
    RA patients of any disease duration, 18 years or older who are starting ABA (either IV or subcutaneous at standard doses) for the first time. Concomitant non-biologic medications (for e.g., standard conventional synthetic (cs)DMARDs, one of which must be MTX as typically used in routine care, or if MTX was not tolerated leflunomide will be acceptable) will be allowed as long as the dose has been stable for at least 3 months.
  • Arm: Arm 2: csDMARD/TNFi Treated
    RA patients, 18 years or older and on stable doses of conventional DMARDs (MTX with or without hydroxychloroquine, sulfasalazine, with or without leflunomide therapy, where leflunomide therapy can be an alternate to MTX). Patient's disease activity can be controlled or near controlled (CDAI \<=12) or active if a recent DMARD or TNFi has been added, though they will have been on MTX at doses of at least 15mg weekly or leflunomide 10 mg or more for 4 weeks or more. A combination of csDMARDs at stable doses for 4 or more weeks with \>= MTX 10 mg weekly or ± MTX 10 mg weekly for at least 4 weeks with any dose of a conventional TNF inhibitor (stable dose + TNFi) is permitted.
  • Arm: Arm 3. Healthy Controls
    Healthy individuals over 18 y.o. without RA, SLE, juvenile arthritis, psoriasis or psoriatic arthritis or other inflammatory auto-immune rheumatic disease, who are receiving care at the HSS or volunteers from the community. Participants will be recruited to serve in the control population for this study. Given that the range of age for most RA patients is between 40-70, we will aim to recruit control volunteers in this age range, ensuring that at least 60% - 70% are female, ensuring an age range and sex that is proportionately similar to the RA population at HSS.

Primary Outcome Measure

Change in clonotype diversity of T cell and B cell repertoires [ Time Frame: April 2024-March 2025 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Margaret Butler
[email protected]
917-260-4906
Caroline Reidy, MPH
[email protected]
646-704-3426
Lou Bridges, MD PhD (PRINCIPAL_INVESTIGATOR)
Vivian P Bykerk, MD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Hospital for Special Surgery· New York, NY

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