NCT03755297

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

November 26, 2018

Last Update Submit

September 24, 2025

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisRegulatory B cellsJAK/STAT inhibitors

Outcome Measures

Primary Outcomes (1)

  • Percentage of regulatory B cells induced by JAKi in vitro

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

    4 months

Secondary Outcomes (2)

  • Percentage of regulatory T cells induced by JAKi treated B cells in vitro

    4 months

  • Percentage of Th1 induced by JAKi treated B cells in vitro

    4 months

Study Arms (3)

Rheumatoid arthritis

OTHER

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

Osteoarthritis

OTHER

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

Other: Blood sample analysis of patients treated as standard care

Rheumatoid arthritis with JAK/STAT inhibitors

OTHER

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

Blood sample analysis of patients treated as standard careOTHER

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

OsteoarthritisRheumatoid arthritisRheumatoid arthritis with JAK/STAT inhibitors

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General criteria
  • Patient, of 18 and more years old
  • Subject affiliated to a social security system
  • Informed consent
  • Rheumatoid arthritis, corresponding to the the classification ACR / EULAR 2010 criteria
  • Spinal degenerative osteoarthritis or degenerative osteoarthritis of the members, according to the clinical and radiological elements.
  • 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.

You may not qualify if:

  • 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
  • Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab) in the previous year
  • History of autoimmune disease or néoplasie
  • Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab)
  • Treatment by rituximab in the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Claire DAIEN, PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 27, 2018

Study Start

February 12, 2019

Primary Completion

August 12, 2022

Study Completion

November 12, 2022

Last Updated

September 30, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)