Status:
TERMINATED
Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Centre National de la Recherche Scientifique, France
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-100 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03755297
Start Date
February 12 2019
End Date
November 12 2022
Last Update
September 30 2025
Active Locations (1)
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1
University Hospital of Montpellier
Montpellier, France, 34