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

University Hospital, Rouen

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT04343378

2019/291/OB

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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