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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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: ."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how immune cells change in people with rheumatoid arthritis (RA) who start abatacept (Orencia), compared with other RA treatments and healthy volunteers. RA causes swollen, painful joints. The study may help explain these symptoms and show who may respond well to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults age 18 or older with RA may qualify. Healthy volunteers must have no autoimmune disease or body-wide inflammatory arthritis.
  • RA must meet the study’s diagnosis rules, fall just one point short while being treated as RA, or have caused typical bone damage.
  • People with RA must take methotrexate (MTX), with or without other standard RA drugs, at steady doses for at least 4 weeks. They must be about to start abatacept or expect to stay on steady RA treatment, which may include a TNF blocker.
  • People starting abatacept should have at least moderate RA activity. Those with a CDAI disease activity score of 2.81–10 need at least two swollen and tender joints.
  • People in the steady-treatment group need a CDAI score below 13 and at least one swollen joint seen by an arthritis doctor in the past 6 months.
  • People with RA must never have taken abatacept or rituximab. Any JAK blocker must have been stopped over 1 month ago, and any IL-6 blocker at least 3 months ago.
  • People with RA may take no more than 10 mg of prednisone daily and must avoid Depo-Medrol or similar steroid shots for 4 weeks before the starting, 3-month, and 6-month visits. Healthy volunteers cannot take prednisone. Steroid inhalers or nasal sprays are allowed.
  • People who can become pregnant must use an accepted form of birth control throughout the study.

Who can't join

  • Severe RA problems that may soon need stronger treatment, such as swelling around the heart or inflamed blood vessels in a major organ.
  • Another autoimmune disease, where the immune system attacks the body, or a body-wide inflammatory rheumatic disease that could affect immune cell results.
  • A serious illness at the same time, such as terminal cancer.
  • A body mass index (BMI), a measure based on height and weight, below 18 or above 40.
  • Past treatment with rituximab, abatacept, or CTLA-4Ig, or use of an experimental drug within 28 days.
  • A live vaccine within 2 weeks before the study starts or at any time during the study.
  • A positive pregnancy test at enrollment or before the study starts, or being unable or unwilling to use accepted birth control while continuing methotrexate.
  • Being part of a vulnerable population; the listing does not define this term.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

NY