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TerminatedNCT03293667CATERLISUpdated Sep 30, 2025

Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis.

An interventional study of Exploratory synovial fluid analysis in Rheumatoid Arthritis, Swelling Joint and Joint Fluid, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 65 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 recrutement / no more PI on this study
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

In rheumatoid arthritis (RA) the clinical response to anti-TNFα is related to an increase in the number or in the function of Treg lymphocytes in the peripheral blood of patients. This observation suggests the central role of Tregs in homeostasis of the immune response during RA.

In the literature the Tregs frequency and phenotype in the peripheral blood are well documented, however the analyses done on the Tregs in inflamed environment are still fragmentary or disparate.

In this project Tregs phenotype as well as expression of several transcripts will be analysed in order to better characterize the Treg cell subsets within the synovial fluid. Moreover, the local inflammatory cytokines (TNF, IL-6 and IL-1) may affect both the phenotype and the suppressive function of these Tregs and a comparison between peripheral and tissue Tregs will allow us to better understand the cause of functional loss.

Outcomes:

Primary outcome: Identification and characterization of the Tregs subpopulation present in the synovial fluid for RA patients suffering an episode of acute arthritis.

Secondary outcomes: compare the phenotypic and expression profile of the Tregs present in the synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from an episode of acute arthritis.

Read the detailed description

Transverse observational, monocentric exploratory study based on physiopathological evaluation Phase of identification/characterization of biomarkers. In a second phase, investigators might also considered a multicentre study with a greater number of patients as well as with osteoarthritis patients in order to validate the specificity of the results obtained in RA.

Investigators will prospectively recruit 10 patients with rheumatoid arthritis suffering from an episode of acute arthritis and requiring joint puncture. Investigators will analyse the cellular component of the joint fluid. It is an interventional clinical trial since one extra blood sample of 30 ml of blood will be collected.

02

Conditions studied

  • Rheumatoid Arthritis
  • Swelling Joint
  • Joint Fluid
  • Characterization of Regulatory T Lymphocytes

Keywords

  • Rheumatoid Arthritis
  • Regulatory T Cells
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 to 65 years old
  • patients with rheumatoid arthritis according to 2010 ACR/EULAR criteria
  • Patients with swelling joint suffering from an episode of acute articular flare link to RA and that requires an aspiration of joint fluid (RA with less than 3 months of evolution confirmed by clinical examination and/or joint ultrasound)
  • Patients who agreed to participate to this study and signs the informed consent form

Exclusion criteria

Exclusion Criteria:

  • Septic arthritis confirmed by microbiological analysis of synovial fluid
  • Osteoarthritis of the reference joint confirmed by X-ray
  • Contraindication for joint aspiration: Platelets \< 50 000/mm3, Prothrombin time \<70%, Partial Thromboplastin Time Blood Test-PTT > 1,5 times compare to the control sample, anticoagulant therapy
  • Biotherapy (including (anti-TNF-α), corticosteroid (orally, intravenously or intra-articulary) or others immunosuppressive drug (current treatment or treatment within 3 months before joint aspiration).
  • Pregnancy, mother in the post natal period or breastfeeding.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Other
    Exploratory arm

    Other: Exploratory synovial fluid analysis

Interventions

  • OtherExploratory synovial fluid analysis

    An additional blood sample (3 10 ml tubes) and an additional specific analysis to characterize subpopulations of regulating T lymphocytes infiltrating the synovium of RA patients and comparing them with those of peripheral blood.

05

What researchers measure

Primary outcomes

  1. Define the heterogeneity of Treg cell subsets

    Description of Treg cell subsets isolated from the synovial fluid of RA patients suffering from an episode of acute arthritis.

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Compare the phenotypic and expression profile of the Tregs

    Comparison between the phenotypic and expression profile of the Tregs present in the synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from an episode of acute arthritis.

    Time frame: Through study completion, an average of 2 years

06

Study locations

1 site
  • Lapeyronie Hospital
    Montpellier, 34295, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03293667
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Sep 26, 2017
Start date
Oct 17, 2017
Primary completion
Jul 27, 2021
Completion
Jul 27, 2021
Last update
Sep 30, 2025

Oversight

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

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