Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells (JAK-INH2)
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample analysis of patients treated as standard care
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Regulatory B cells, JAK/STAT inhibitors
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
Sites / Locations
- University Hospital of Montpellier
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Rheumatoid arthritis
Osteoarthritis
Rheumatoid arthritis with JAK/STAT inhibitors
Arm Description
Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care
Control patients and Blood sample analysis of patients treated as standard care
Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care
Outcomes
Primary Outcome Measures
Percentage of regulatory B cells induced by JAKi in vitro
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
CD25hiCD126lo/-CD4+ after 3 days of coculture with JAKi pretreated B cells
Percentage of Th1 induced by JAKi treated B cells in vitro
Interferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells
Full Information
NCT ID
NCT03755297
First Posted
November 26, 2018
Last Updated
September 13, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03755297
Brief Title
Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
Acronym
JAK-INH2
Official Title
Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Default of recruitment
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
November 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France, Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Regulatory B cells, JAK/STAT inhibitors
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rheumatoid arthritis
Arm Type
Other
Arm Description
Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care
Arm Title
Osteoarthritis
Arm Type
Other
Arm Description
Control patients and Blood sample analysis of patients treated as standard care
Arm Title
Rheumatoid arthritis with JAK/STAT inhibitors
Arm Type
Other
Arm Description
Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care
Intervention Type
Other
Intervention Name(s)
Blood sample analysis of patients treated as standard care
Intervention Description
Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)
Primary Outcome Measure Information:
Title
Percentage of regulatory B cells induced by JAKi in vitro
Description
IL-10+ CD19+ cells after in vitro exposure of JAKi
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Percentage of regulatory T cells induced by JAKi treated B cells in vitro
Description
CD25hiCD126lo/-CD4+ after 3 days of coculture with JAKi pretreated B cells
Time Frame
4 months
Title
Percentage of Th1 induced by JAKi treated B cells in vitro
Description
Interferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire DAIEN, PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
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