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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03755297
Acronym
JAK-INH2
Enrollment
27
Registered
2018-11-27
Start date
2019-02-12
Completion date
2022-11-12
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Regulatory B cells, JAK/STAT inhibitors

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.

Interventions

OTHERBlood sample analysis of patients treated as standard care

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

Sponsors

Centre National de la Recherche Scientifique, France
CollaboratorOTHER
Pfizer
CollaboratorINDUSTRY
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of regulatory B cells induced by JAKi in vitro4 monthsIL-10+ CD19+ cells after in vitro exposure of JAKi

Secondary

MeasureTime frameDescription
Percentage of regulatory T cells induced by JAKi treated B cells in vitro4 monthsCD25hiCD126lo/-CD4+ after 3 days of coculture with JAKi pretreated B cells
Percentage of Th1 induced by JAKi treated B cells in vitro4 monthsInterferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026