<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03293667</url>
  </required_header>
  <id_info>
    <org_study_id>9747</org_study_id>
    <nct_id>NCT03293667</nct_id>
  </id_info>
  <brief_title>Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis.</brief_title>
  <acronym>CATERLIS</acronym>
  <official_title>Phenotypic and Functional Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis, a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In rheumatoid arthritis (RA) the clinical response to anti-TNFα is related to an increase in&#xD;
      the number or in the function of Treg lymphocytes in the peripheral blood of patients. This&#xD;
      observation suggests the central role of Tregs in homeostasis of the immune response during&#xD;
      RA.&#xD;
&#xD;
      In the literature the Tregs frequency and phenotype in the peripheral blood are well&#xD;
      documented, however the analyses done on the Tregs in inflamed environment are still&#xD;
      fragmentary or disparate.&#xD;
&#xD;
      In this project Tregs phenotype as well as expression of several transcripts will be analysed&#xD;
      in order to better characterize the Treg cell subsets within the synovial fluid. Moreover,&#xD;
      the local inflammatory cytokines (TNF, IL-6 and IL-1) may affect both the phenotype and the&#xD;
      suppressive function of these Tregs and a comparison between peripheral and tissue Tregs will&#xD;
      allow us to better understand the cause of functional loss.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      Primary outcome: Identification and characterization of the Tregs subpopulation present in&#xD;
      the synovial fluid for RA patients suffering an episode of acute arthritis.&#xD;
&#xD;
      Secondary outcomes: compare the phenotypic and expression profile of the Tregs present in the&#xD;
      synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from&#xD;
      an episode of acute arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transverse observational, monocentric exploratory study based on physiopathological&#xD;
      evaluation Phase of identification/characterization of biomarkers. In a second phase,&#xD;
      investigators might also considered a multicentre study with a greater number of patients as&#xD;
      well as with osteoarthritis patients in order to validate the specificity of the results&#xD;
      obtained in RA.&#xD;
&#xD;
      Investigators will prospectively recruit 10 patients with rheumatoid arthritis suffering from&#xD;
      an episode of acute arthritis and requiring joint puncture. Investigators will analyse the&#xD;
      cellular component of the joint fluid. It is an interventional clinical trial since one extra&#xD;
      blood sample of 30 ml of blood will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Default of recrutement / no more PI on this study&#xD;
  </why_stopped>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Actual">July 27, 2021</completion_date>
  <primary_completion_date type="Actual">July 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Define the heterogeneity of Treg cell subsets</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Description of Treg cell subsets isolated from the synovial fluid of RA patients suffering from an episode of acute arthritis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the phenotypic and expression profile of the Tregs</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Swelling Joint</condition>
  <condition>Joint Fluid</condition>
  <condition>Characterization of Regulatory T Lymphocytes</condition>
  <arm_group>
    <arm_group_label>Exploratory arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exploratory synovial fluid analysis</intervention_name>
    <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.</description>
    <arm_group_label>Exploratory arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 65 years old&#xD;
&#xD;
          -  patients with rheumatoid arthritis according to 2010 ACR/EULAR criteria&#xD;
&#xD;
          -  Patients with swelling joint suffering from an episode of acute articular flare link&#xD;
             to RA and that requires an aspiration of joint fluid (RA with less than 3 months of&#xD;
             evolution confirmed by clinical examination and/or joint ultrasound)&#xD;
&#xD;
          -  Patients who agreed to participate to this study and signs the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Septic arthritis confirmed by microbiological analysis of synovial fluid&#xD;
&#xD;
          -  Osteoarthritis of the reference joint confirmed by X-ray&#xD;
&#xD;
          -  Contraindication for joint aspiration: Platelets &lt; 50 000/mm3, Prothrombin time &lt;70%,&#xD;
             Partial Thromboplastin Time Blood Test-PTT &gt; 1,5 times compare to the control sample,&#xD;
             anticoagulant therapy&#xD;
&#xD;
          -  Biotherapy (including (anti-TNF-α), corticosteroid (orally, intravenously or&#xD;
             intra-articulary) or others immunosuppressive drug (current treatment or treatment&#xD;
             within 3 months before joint aspiration).&#xD;
&#xD;
          -  Pregnancy, mother in the post natal period or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lapeyronie Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>March 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Regulatory T Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293667
org study id: 9747
nct id: NCT03293667
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Define the heterogeneity of Treg cell subsets
time frame: Through study completion, an average of 2 years
description: Description of Treg cell subsets isolated from the synovial fluid of RA patients suffering from an episode of acute arthritis.
measure: Compare the phenotypic and expression profile of the Tregs
time frame: Through study completion, an average of 2 years
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.
arm group label: Exploratory arm
arm group type: Other
intervention type: Other
intervention name: Exploratory synovial fluid analysis
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.
arm group label: Exploratory arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No