Prediction of Abatacept Discontinuation Using Test Reflecting Immunological Remission in Rheumatoid Arthritis

Last updated: March 3, 2025
Sponsor: University Hospital, Rouen
Overall Status: Completed

Phase

N/A

Condition

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT04343378
2019/291/OB
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to identify a panel of immunological molecular and cellular biomarkers able to predict the success of major dose-reduction or discontinuation of abatacept in rheumatoid arthritis patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Rheumatoid arthritis (RA) patients (> pr = 18 years) fulfilling the 2010 ACR/EULARcriteria

  • Associated to high levels (> 3 x upper limit of normal in UA/ml) of ACPA measured bythe usual anti-CCP(cyclic citrullinated proteins)2 test at the start of abatacepttreatment

  • Receiving IV (intravenous) or SC (subcutaneous) abatacept alone or in combinationwith a conventional Disease Modyfying AntiRheumatic Drugs (cDMARD) (methotrexate,leflunomide, sulfasalasin in monotherapy or in combination) according to the usualscheme or in tapering phase

  • Without intra-articular injections of corticosteroids during the last 6 months priorto 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 withoutclinical synovitis) since at least 1 year

  • In sonographic remission at the time of enrollment (absence of PD (PowerDoppler)-positive synovitis on 28 joints defined by a score < 2 on a 0-3semi-quantitative scale for each joint)

Exclusion

Exclusion Criteria:

  • Age < 18 years

  • RA negative for ACPA (anti-citrullinated proteins antibodies) or not fulfillingACR/EULAR criteria

  • Abatacept discontinuation due to serious adverse event, loss of efficacy orpregnancy project

Study Design

Total Participants: 40
Study Start date:
June 08, 2020
Estimated Completion Date:
November 14, 2024

Study Description

Parameters studied at different time points (before initiation of abatacept if sample is available in our biocollection; prior to dose tapering; prior to discontinuation) ACPA (anti-citrullinated proteins antibodies) repertoire

-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

Connect with a study center

  • Rouen University Hospital

    Rouen,
    France

    Site Not Available

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