Scientists peek inside immune system to see why some arthritis drugs work better
NCT ID NCT05782335
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with rheumatoid arthritis who are starting a drug called abatacept (Orencia). Researchers want to see how this drug changes certain immune cells (T and B cells) in the blood over 6 months. They will compare these changes to those in people taking other arthritis drugs and in healthy volunteers. The goal is to learn more about why joints swell and hurt, and possibly find clues to predict who will respond well to treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital for Special Surgery
RECRUITINGNew York, New York, 10021, United States
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