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

NCT ID: NCT03755297

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2022-11-12

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Rheumatoid arthritis

Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care

Group Type: OTHER

Blood sample analysis of patients treated as standard care

Intervention Type: OTHER

Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)

Osteoarthritis

Control patients and Blood sample analysis of patients treated as standard care

Group Type: OTHER

Blood sample analysis of patients treated as standard care

Intervention Type: OTHER

Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)

Rheumatoid arthritis with JAK/STAT inhibitors

Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care

Group Type: OTHER

Blood sample analysis of patients treated as standard care

Intervention Type: OTHER

Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)

Interventions

Blood sample analysis of patients treated as standard care

Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire DAIEN, PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

University Hospital of Montpellier

Montpellier, , France

Countries

France

Other Identifiers

2017-A03095-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL17_0393

Identifier Type: -

Identifier Source: org_study_id