Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02885818
• Lead Sponsor: University Hospital, Brest

Brief Summary

Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-01
• Primary Completion: 2018-01-11
• Study Completion: 2018-01-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• RA as defined by ACR/EULAR criteria
• Clinical indication to start abatacept therapy

Exclusion Criteria

• Treatment by rituximab in the previous year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral blood B-cell phenotype changes	3 months	Measure of the proportion of the main B-cell subsets (transitional, naïve, memory, plasmablasts) by FACS analysis before abatacept initiation and 3 months later.

Secondary Outcome Measures

Name	Time	Method
In vitro B-cell function and regulatory properties	3 months	In vitro culture of B cells from the patients to assess B cell inhibition of T cell proliferation before abatacept initiation and 3 months later.

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France