Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03755297
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

This study will investigate whether inhibitors of the JAK / STAT signaling pathway can increase anti-inflammatory functions of B cells in patients with RA using in vitro and in vivo experiments.

Detailed Description

This study will first analyze the effect of inhibitors of the JAK / STAT pathway in vitro on B-cell phenotypes and functions in 30 RA patients and 30 patients with osteoarthritis. It will also study the phenotypes and functions of B cells in RA patients for whom JAK / STAT inhibitor treatment has been prescribed by the patient's usual rheumatologist. The analysis will be done before the start of treatment and 3 months later. The phenotypes of B-cells will be assessed by flow cytometry with intra- and extra-cellular stainings. The functions of B cells will be assessed by their ability to differenciate naïve T cells in coculture.

Study Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Start: 2019-02-12
• Primary Completion: 2022-08-12
• Study Completion: 2022-11-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of regulatory B cells induced by JAKi in vitro	4 months	IL-10+ CD19+ cells after in vitro exposure of JAKi

Secondary Outcome Measures

Name	Time	Method
Percentage of Th1 induced by JAKi treated B cells in vitro	4 months	Interferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells
Percentage of regulatory T cells induced by JAKi treated B cells in vitro	4 months	CD25hiCD126lo/-CD4+ after 3 days of coculture with JAKi pretreated B cells

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, France