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Rheumatoid ArthritisNCT05782335

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

An observational study of Rheumatoid Arthritis, run by Hospital for Special Surgery, New York at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis
Type of treatment
Injection or infusion
How many people
72 participants
Where
1 siteUnited States
Study dates
1 Nov 2022to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population is patients with RA who are starting ABA. Data from the study population will be compared with RA controls being treated with standard of care therapy, i.e., MTX with or without either other conventional synthetic (cs)DMARDs and/or a TNF inhibitor (etanercept, adalimumab, golimumab, infliximab, certolizumab pegol). RA patients who enter the study must meet inclusion criteria.

Inclusion Criteria: M or F >=18 y.o. with diagnosed RA. Disease related inclusion criteria:

  1. Patients being treated with MTX with or without csDMARDS at stable doses for at least 4 weeks, who are either: (a) about to start ABA, OR, (b) who are likely to remain on stable DMARDs and who might also be using a TNFi but in whom all therapies will have been stable for 4 or more weeks.

2.) meet diagnostic criteria for RA, based on 2010 ACR Criteria or 1987 RA criteria, OR, are one point short of meeting the criteria but are being treated for RA, OR, have previously identified RA typical erosions.

  1. have never received ABA or rituximab, and, if previously used a JAKi, will have stopped this for over a month, OR, if previously used an IL-6 inhibitor, will have stopped for at least 3 months.
  2. RA subject must not be taking prednisone at doses over 10 mg daily, and will not have received injectable Depomedrol or equivalent within 4 weeks of baseline or prior to the 3 or 6 month study assessment. Healthy control patients cannot be taking prednisone. Any subject can use oral or nasal inhalers that include glucocorticoids 5) have evidence of recent or currently active disease depending on treatment arm. Subjects starting ABA (Arm 1) are expected to have at least moderate disease activity, OR if CDAI is between 2.81 and 10, there should be two or more swollen and tender joints. For subjects being included in Arm 2, the stable treatment arm, CDAI <13 and one swollen joint observed by a rheumatologist in the prior 6 months. Subjects recruited to the healthy control arm (Arm 3) will be free of any autoimmune disease or systemic form of an inflammatory arthritis.
  3. WOCBP must be using acceptable forms of contraception to avoid pregnancy throughout the study, i.e. oral contraceptives, other hormonal contraceptives.

Specific Exclusion Criteria:

  1. Have severe complications of RA that might require imminent escalation of therapy, e.g. pericarditis, active vasculitis of a major organ system.
  2. Have an autoimmune disease or systemic inflammatory rheumatic disease (e.g., lupus erythematosus) that could confound T and B cell subset results
  3. Have a concurrent serious medical disease (e.g., terminal malignancy)
  4. Have a BMI indicating poor health (<18 or > 40)
  5. Have received the following Prohibited Treatments and/or Therapies
  6. treatment with rituximab
  7. exposed to ABA or CTLA-4Ig
  8. exposed to any investigational drug within 28 days.
  9. received any live vaccines within 2 weeks prior to study start. Subjects cannot receive a live vaccine at any time during the study.
  10. WOCBP with a positive pregnancy test on enrollment or prior to study start, OR who are unwilling or unable to use an acceptable method to avoid pregnancy despite continuing MTX.
  11. part of a vulnerable population

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Margaret Butler, BS contact

917-260-4906

ButlerM@hss.edu

Caroline Reidy, MPH contact

646-704-3426

ReidyC@hss.edu

United States1 site, 1 recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Margaret Butler, 917-260-4906, ButlerM@hss.edu

    Caroline Reidy, MPH, 646-704-3426, ReidyC@hss.edu

    Recruiting

Other trials in United States

About this study

Official title: Analysis of T and B Cell Repertoire Changes and CTLA4 Genetics and Gene Expression to Understand the Mechanisms of Treatment Response to Orencia ® (Abatacept) in Rheumatoid Arthritis

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.

Read the detailed description

This is a mechanistic study examining changes in repertoires of both T cell receptors (TCR) and B cell receptors (BCR) in patients with RA initiating ABA treatment and who are followed for 6 months relative to changes in repertoires of both TCRs and BCRs in two similarly followed comparator groups: . Patterns of T and B cell repertoires in the group of patients with RA initiating treatment with ABA will be compared to (i) RA patients on stable therapy with methotrexate (MTX) or leflunomide (LEF) with or without TNF inhibitors and (ii) "controls" matched for age (+/- 7 years) and sex (approximately 75% female +/- 5%). Our primary hypothesis is that ABA treatment will affect the immune repertoires both in TCR and BCR and the distribution of immune cell subsets (particularly B cell subsets) over time to a greater extent than non-ABA treated RA patients and "controls".

The goal is to determine how abatacept changes the repertoires of both TCRs and BRCs compared to control groups. The investigators anticipate that the repertoires will change differently in ABA treated patients over time relative to similar RA patients treated with conventional synthetic DMARDS (MTX and / or Leflunomide), with or without the use of a TNF inhibitor (TNFi). Changes in repertoires will also be compared to "controls" with no inflammatory disease.with proportionately similar proportions of anti-CCP3 positivity, (but not anti-IL-6 therapy, Jak Kinase Inhibitors (JAKi's) or Rituximab)

A total of 72 people will participate in this study at HSS in 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)

Once enrolled, these participants will be assessed at their baseline visit and seen 3 months and 6 months after baseline. These visits will involve a blood draw and questionnaires related to functioning and feeling with RA (where applicable) and may take up to an hour. Participants will be compensated per visit.

Keywords
abatacept, b cell repertoire, t cell repertoire
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05782335
Study groupRoleWhat they receive
Arm 1: Abatacept InitiatorRA 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 2: csDMARD/TNFi TreatedRA 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 3. Healthy ControlsHealthy 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in clonotype diversity of T cell and B cell repertoires

    Investigators will compare the change in clonotype diversity of T cell and B cell repertoires in patients over 6 months by analyzing clonotype diversity of T cell and B cell repertoires at BL (pre-treatment), 3 months, and 6 months post treatment for each individual in each of the three groups (RA starting ABA; RA on stable MTX +/- TNFi.

    Measured: April 2024-March 2025

Secondary outcomes (3)

  1. CTLA4 gene expression in peripheral blood at 3 times points

    Investigators will assess changes in CTLA4 gene expression in peripheral blood at BL, and at 3 and 6 months post-treatment.

    Measured: April 2024-March 2025

  2. Changes in the proportions of T and B cell subtypes

    Changes in the proportions of T and B cell subtypes well as NK cells associated with ABA treatment. Flow cytometry analysis will be used to quantify the frequency of T and B cell subtypes and NK cells at each timepoint in each subject in each Arm.

    Measured: April 2024-March 2025

  3. Expression levels in peripheral blood of genes key to the immune response.

    Changes in expression levels in peripheral blood of 150 genes key to the immune response.

    Measured: April 2024-March 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2023
  2. Study start1 Nov 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05782335
Sponsor's protocol ID
2021-0142
Status last verified
Jan 2026
First submitted
16 Feb 2023
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Margaret Butler, BS (917-260-4906, ButlerM@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in clonotype diversity of T cell and B cell repertoires (time frame: April 2024-March 2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05782335.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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