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

NCT04343378 | Completed

• 1 other identifier: 2019/291/OB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Keywords

therapy discontinuation

Outcome Measures

Primary Outcomes (1)

• relapse

  Increase of DAS(Disease Activity Score)28 ESR (or CRP) \> 3.2 at 2 consecutive time points.

  from date of inclusion until the date of documented flare assessed up to 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All ACPA + RA patients from the rheumatology department of Rouen University Hospital receiving IV (intravenous) or SC (subcutaneous) abatacept (according to the usual scheme or having started tapering) and in deep remission (as defined previously) will be included.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum; PAXgene tubes, cellular samples

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Olivier VITTECOQ, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: April 13, 2020
• Study Start: June 8, 2020
• Primary Completion: November 13, 2024
• Study Completion: November 14, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)