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

Rheumatoid Arthritis Clinical Trial

— JAK-INH2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03755297
• Other study ID #: 5601
• Status: Terminated
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: November 12, 2022

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: November 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Blood sample analysis of patients treated as standard care
Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre National de la Recherche Scientifique, France, Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of regulatory B cells induced by JAKi in vitro	IL-10+ CD19+ cells after in vitro exposure of JAKi	4 months
Secondary	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
Secondary	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