Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells (JAK-INH2)

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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Blood sample analysis of patients treated as standard care

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• General criteria
• Patient, of 18 and more years old
• Subject affiliated to a social security system
• Subject not being in period of exclusion with regard to another protocol
• Absence of pregnancy in the inclusion (date of the last period, use of a contraceptive method, ß -HCG impulsive person in case of doubt)
• Informed consent
• Criteria of inclusion of the group rheumatoid arthritis (in vitro studies):
• Rheumatoid arthritis, corresponding to the the classification ACR / EULAR 2010 criteria
• Criteria of inclusion of the group arthritis (in vitro studies):
• Spinal degenerative osteoarthritis or degenerative osteoarthritis of the members, according to the clinical and radiological elements.
• Criteria of inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by JAK / STAT inhibitors :
• Rheumatoid Polyarthritis, corresponding to the classification ACR / EULAR 2010 criteria
• Patient to whom a treatment by inhibitor of the way JAK / STAT was proposed in current care of rheumatoid arthritis.

Exclusion criteria:

• General criteria
• Corticosteroid therapy superior to 10 mg / j
• Drip of corticoids in the previous month
• Pregnant or breast-feeding Patients
• Patient under protection(saving) of justice
• Under guardianship Patient or guardianship
• Current Infection
• Criteria of non-inclusion of the group rheumatoid polyarthritis ( in vitro studies):
• Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab) in the previous year
• Criteria of non-inclusion of the group arthritis ( in vitro studies):
• History of autoimmune disease or néoplasie
• Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab)
• Criteria of non-inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by JAK / STAT inhibitors :

Treatment by rituximab in the previous year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Rheumatoid arthritis; Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care	Other: Blood sample analysis of patients treated as standard care; Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)
Other: Osteoarthritis; Control patients and Blood sample analysis of patients treated as standard care	Other: Blood sample analysis of patients treated as standard care; Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)
Other: Rheumatoid arthritis with JAK/STAT inhibitors; Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care	Other: Blood sample analysis of patients treated as standard care; Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of regulatory B cells induced by JAKi in vitro	IL-10+ CD19+ cells after in vitro exposure of JAKi	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Pfizer; Centre National de la Recherche Scientifique, France
• Investigators: Principal Investigator: Claire DAIEN, PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): November 12, 2022

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; Regulatory B cells; JAK/STAT inhibitors
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: RECHMPL17_0393; 2017-A03095-48 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No