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TerminatedNCT03755297JAK-INH2Updated Sep 30, 2025

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

An interventional study of Blood sample analysis of patients treated as standard care in Rheumatoid Arthritis, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Basic science

Why this study was terminated
Default of recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid arthritis
  • Regulatory B cells
  • JAK/STAT inhibitors
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 27 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • 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

  • Other
    Osteoarthritis

    Control patients and Blood sample analysis of patients treated as standard care

    Other: Blood sample analysis of patients treated as standard care

  • 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

Interventions

  • OtherBlood sample analysis of patients treated as standard care

    Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)

06

What researchers measure

Primary outcomes

  1. Percentage of regulatory B cells induced by JAKi in vitro

    IL-10+ CD19+ cells after in vitro exposure of JAKi

    Time frame: 4 months

Secondary outcomes

  1. 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

    Time frame: 4 months

  2. Percentage of Th1 induced by JAKi treated B cells in vitro

    Interferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells

    Time frame: 4 months

07

Study locations

1 site
  • University Hospital of Montpellier
    Montpellier, 34, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03755297
Lead sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France, Pfizer
Responsible party
Sponsor
First posted
Nov 27, 2018
Start date
Feb 12, 2019
Primary completion
Aug 12, 2022
Completion
Nov 12, 2022
Last update
Sep 30, 2025

Study contacts

Claire DAIEN, PH
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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