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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

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

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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

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