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Completed

NCT Number: NCT04343378

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rouen University Hospital

Rouen, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. relapse

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: PADIRRA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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