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

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Blood sample analysis of patients treated as standard care

• 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

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis	Blood sample analysis of patients treated as standard care	Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care
Osteoarthritis	Blood sample analysis of patients treated as standard care	Control patients and Blood sample analysis of patients treated as standard care
Rheumatoid arthritis with JAK/STAT inhibitors	Blood sample analysis of patients treated as standard care	Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care

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