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Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells (JAK-INH2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755297
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : January 13, 2022
Sponsor:
Collaborators:
Centre National de la Recherche Scientifique, France
Pfizer
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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
Rheumatoid Arthritis Other: Blood sample analysis of patients treated as standard care Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)
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)
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
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Primary Outcome Measures :
  1. Percentage of regulatory B cells induced by JAKi in vitro [ Time Frame: 4 months ]
    IL-10+ CD19+ cells after in vitro exposure of JAKi


Secondary Outcome Measures :
  1. Percentage of regulatory T cells induced by JAKi treated B cells in vitro [ Time Frame: 4 months ]
    CD25hiCD126lo/-CD4+ after 3 days of coculture with JAKi pretreated B cells

  2. Percentage of Th1 induced by JAKi treated B cells in vitro [ Time Frame: 4 months ]
    Interferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755297


Contacts
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Contact: Claire DAIEN, PH 0685402787 c-daien@chu-montpellier.fr
Contact: Sophie BARRAT, CRA s-barrat@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier Recruiting
Montpellier, France, 34
Contact: Claire Daien         
Contact: Guillaume Decarriere         
Sponsors and Collaborators
University Hospital, Montpellier
Centre National de la Recherche Scientifique, France
Pfizer
Investigators
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Principal Investigator: Claire DAIEN, PH University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03755297    
Other Study ID Numbers: 5601
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Rheumatoid arthritis
Regulatory B cells
JAK/STAT inhibitors
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases