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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2023
  • participants needed
    60
  • sponsor
    University Hospital, Rouen
Updated on 25 January 2021
corticosteroids
remission
methotrexate
leflunomide
synovitis
abatacept
antirheumatics
cyclic citrullinated peptide antibody

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

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

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric), Rheumatoid Arthritis (Pediatric)
Clinical Study IdentifierNCT04343378
SponsorUniversity Hospital, Rouen
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Age < 18 years
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
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