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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04343378

Acronym

PADIRRA

Enrollment

Registered

2020-04-13

Start date

2020-06-08

Completion date

2024-11-14

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

therapy discontinuation

Brief 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

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
relapse	from date of inclusion until the date of documented flare assessed up to 24 months	Increase of DAS(Disease Activity Score)28 ESR (or CRP) \> 3.2 at 2 consecutive time points.

Countries

France

Outcome results