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Trial record 1 of 1 for:    NCT03755297
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Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells (JAK-INH2)

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ClinicalTrials.gov Identifier: NCT03755297
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
Centre National de la Recherche Scientifique, France
Pfizer
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE November 26, 2018
First Posted Date  ICMJE November 27, 2018
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE February 12, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
Percentage of regulatory B cells induced by JAKi in vitro [ Time Frame: 4 months ]
IL-10+ CD19+ cells after in vitro exposure of JAKi
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
Official Title  ICMJE Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Other: Blood sample analysis of patients treated as standard care
Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)
Study Arms  ICMJE
  • Rheumatoid arthritis
    Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care
    Intervention: Other: Blood sample analysis of patients treated as standard care
  • Osteoarthritis
    Control patients and Blood sample analysis of patients treated as standard care
    Intervention: Other: Blood sample analysis of patients treated as standard care
  • Rheumatoid arthritis with JAK/STAT inhibitors
    Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care
    Intervention: Other: Blood sample analysis of patients treated as standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claire DAIEN, PH 0685402787 c-daien@chu-montpellier.fr
Contact: Sophie BARRAT, CRA s-barrat@chu-montpellier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03755297
Other Study ID Numbers  ICMJE 5601
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE
  • Centre National de la Recherche Scientifique, France
  • Pfizer
Investigators  ICMJE
Principal Investigator: Claire DAIEN, PH University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP