Prediction of Abatacept Discontinuation Using Test Reflecting Immunological Remission in Rheumatoid Arthritis
NCT ID: NCT04343378
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2020-06-08
2024-11-14
Brief Summary
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Detailed Description
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-IgG (Immunoglobulins G) and/or IgA auto-antibodies repertoire directed against major epitopes of well-known autoantigens
B cell repertoire B cell repertoire and transcriptome of regulatory B lymphocytes, memory B cells and B cells targeting specific autoantigens.
Analysis of type I interferon signature Expression levels of 7 type I interferon (IFN) response genes will be determined to calculate on type I IFN score
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Associated to high levels (\> 3 x upper limit of normal in UA/ml) of ACPA measured by the usual anti-CCP(cyclic citrullinated proteins)2 test at the start of abatacept treatment
* Receiving IV (intravenous) or SC (subcutaneous) abatacept alone or in combination with a conventional Disease Modyfying AntiRheumatic Drugs (cDMARD) (methotrexate, leflunomide, sulfasalasin in monotherapy or in combination) according to the usual scheme or in tapering phase
* Without intra-articular injections of corticosteroids during the last 6 months prior to down-titration of abatacept
* Having discontinued corticosteroids at he time of entrance in the study
* In deep remission (Disease Activity Score (DAS) 28 ESR (or CRP) \< 2.6 without clinical synovitis) since at least 1 year
* In sonographic remission at the time of enrollment (absence of PD (Power Doppler)-positive synovitis on 28 joints defined by a score \< 2 on a 0-3 semi-quantitative scale for each joint)
Exclusion Criteria
* RA negative for ACPA (anti-citrullinated proteins antibodies) or not fulfilling ACR/EULAR criteria
* Abatacept discontinuation due to serious adverse event, loss of efficacy or pregnancy project
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Olivier VITTECOQ, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2019/291/OB
Identifier Type: -
Identifier Source: org_study_id
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