Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis. (CATERLIS)
Primary Purpose
Rheumatoid Arthritis, Swelling Joint, Joint Fluid
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exploratory synovial fluid analysis
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Regulatory T Cells
Eligibility Criteria
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:
- 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.
Sites / Locations
- Lapeyronie Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exploratory arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03293667
First Posted
March 16, 2017
Last Updated
September 11, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03293667
Brief Title
Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis.
Acronym
CATERLIS
Official Title
Phenotypic and Functional Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis, a Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Default of recrutement / no more PI on this study
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
July 27, 2021 (Actual)
Study Completion Date
July 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Swelling Joint, Joint Fluid, Characterization of Regulatory T Lymphocytes
Keywords
Rheumatoid Arthritis, Regulatory T Cells
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exploratory arm
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Exploratory synovial fluid analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Define the heterogeneity of Treg cell subsets
Description
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 Outcome Measure Information:
Title
Compare the phenotypic and expression profile of the Tregs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Facility Information:
Facility Name
Lapeyronie Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis.
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