Rheumatoid ArthritisCATERLISNCT03293667
Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis.
A study testing Exploratory synovial fluid analysis in people with Rheumatoid Arthritis and Swelling Joint, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, Swelling Joint, Joint Fluid
- What is being tested?
- Exploratory synovial fluid analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2017to 27 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotypic and Functional Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis, a Pilot Study.
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.
Read more
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.
- Conditions
- Rheumatoid Arthritis, Swelling Joint, Joint Fluid, Characterization of Regulatory T Lymphocytes
- Being tested
- Exploratory synovial fluid analysis
- Keywords
- Rheumatoid Arthritis, Regulatory T Cells
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploratory synovial fluid analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exploratory arm | Other | Not described Receives: Other: Exploratory synovial fluid analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start17 Oct 2017
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Why it stopped: Default of recrutement / no more PI on this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293667
- Sponsor's protocol ID
- RECHMPL16_0264
- Other IDs
- 2016-A01489-42
- Acronym
- CATERLIS
- Status last verified
- Sep 2023
- First submitted
- 16 Mar 2017
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Functional Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis, a Pilot Study.
- ClinicalTrials.gov ID
- NCT03293667
- Acronym / sponsor ID
- CATERLIS / RECHMPL16_0264
- Conditions
- Rheumatoid Arthritis, Swelling Joint, Joint Fluid, Characterization of Regulatory T Lymphocytes
- Keywords
- Rheumatoid Arthritis, Regulatory T Cells
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Default of recrutement / no more PI on this study
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exploratory arm | Other | Other: Exploratory synovial fluid analysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exploratory synovial fluid analysisAn 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. | Other | Exploratory arm |
Primary outcome
Define the heterogeneity of Treg cell subsets
Time frame: Through study completion, an average of 2 years
Description of Treg cell subsets isolated from the synovial fluid of RA patients suffering from an episode of acute arthritis.
1 secondary outcome
Compare the phenotypic and expression profile of the Tregs
Time frame: Through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Default of recrutement / no more PI on this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exploratory synovial fluid analysis in people with Rheumatoid Arthritis and Swelling Joint, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Default of recrutement / no more PI on this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the heterogeneity of Treg cell subsets (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.