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

NCT ID
NCT05782335
Registry status
Recruiting
Study type
Observational
Sponsor
Hospital for Special Surgery, New York
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 72 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility 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. 3\) 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. 4\) 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. 6\) 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 1. treatment with rituximab 2. exposed to ABA or CTLA-4Ig 3. exposed to any investigational drug within 28 days. 4. received any live vaccines within 2 weeks prior to study start. Subjects cannot receive a live vaccine at any time during the study. 6. 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. 7. part of a vulnerable population

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • Hospital for Special Surgery — New York, New York, 10021, United States — Recruiting

Study details

Start date
November 1, 2022
Primary completion date
December 1, 2026
Completion date
December 1, 2026
First posted
March 23, 2023

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05782335
Registry last updated
February 13, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT05782335 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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