JAK-INH2: Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Percentage of regulatory B cells induced by JAKi in vitro [4 months]
IL-10+ CD19+ cells after in vitro exposure of JAKi
Secondary Outcome Measures
- Percentage of regulatory T cells induced by JAKi treated B cells in vitro [4 months]
CD25hiCD126lo/-CD4+ after 3 days of coculture with JAKi pretreated B cells
- Percentage of Th1 induced by JAKi treated B cells in vitro [4 months]
Interferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells
Eligibility Criteria
Criteria
Inclusion criteria:
-
General criteria
-
Patient, of 18 and more years old
-
Subject affiliated to a social security system
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Subject not being in period of exclusion with regard to another protocol
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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):
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Rheumatoid arthritis, corresponding to the the classification ACR / EULAR 2010 criteria
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Criteria of inclusion of the group arthritis (in vitro studies):
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Spinal degenerative osteoarthritis or degenerative osteoarthritis of the members, according to the clinical and radiological elements.
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Criteria of inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by JAK / STAT inhibitors :
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Rheumatoid Polyarthritis, corresponding to the classification ACR / EULAR 2010 criteria
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Patient to whom a treatment by inhibitor of the way JAK / STAT was proposed in current care of rheumatoid arthritis.
Exclusion criteria:
-
General criteria
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Corticosteroid therapy superior to 10 mg / j
-
Drip of corticoids in the previous month
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Pregnant or breast-feeding Patients
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Patient under protection(saving) of justice
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Under guardianship Patient or guardianship
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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):
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History of autoimmune disease or néoplasie
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Montpellier | Montpellier | France | 34 |
Sponsors and Collaborators
- University Hospital, Montpellier
- Centre National de la Recherche Scientifique, France
- Pfizer
Investigators
- Principal Investigator: Claire DAIEN, PH, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5601