<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/NCT03280797</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2016/TAT01</org_study_id>
    <nct_id>NCT03280797</nct_id>
  </id_info>
  <brief_title>Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases</brief_title>
  <acronym>IL-MAI</acronym>
  <official_title>Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      This study will assess the feasibility of using cytokine expression profiles in blood samples&#xD;
      as a method for evaluating rheumatoid polyarthritis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Actual">January 12, 2022</completion_date>
  <primary_completion_date type="Actual">February 8, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dosage of cytokines between groups</measure>
    <time_frame>Day 0</time_frame>
    <description>Concentration measured by ELISA and flow cytometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Creation of biobank</measure>
    <time_frame>Day 0</time_frame>
    <description>Storage of blood samples</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>2ml blood taken into TruCulture tube</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Rheumatoid arthritis patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given their free and informed consent and signed the consent&#xD;
             form&#xD;
&#xD;
          -  The patient must be a member or beneficiary of a health insurance plan&#xD;
&#xD;
          -  Patient is at least 18 years old&#xD;
&#xD;
          -  Subjects included as patients have rheumatoid polyarthritis according to ACR EULA&#xD;
             2010, DAS28&gt;3.2 criteria&#xD;
&#xD;
          -  Subjects included as controls are healthy volunteers who have no overexpression of&#xD;
             cytokines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is participating in an interventional study, or is in a period of&#xD;
             exclusion determined by a previous study&#xD;
&#xD;
          -  The subject refuses to sign the consent&#xD;
&#xD;
          -  It is impossible to give the subject informed information&#xD;
&#xD;
          -  The patient has had at least 3 months of specific treatment that can potentially&#xD;
             impact cytokine profile&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immune System Diseases</mesh_term>
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03280797
org study id: LOCAL/2016/TAT01
nct id: NCT03280797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess the feasibility of using cytokine expression profiles in blood samples
      as a method for evaluating rheumatoid polyarthritis
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Dosage of cytokines between groups
time frame: Day 0
description: Concentration measured by ELISA and flow cytometry
measure: Creation of biobank
time frame: Day 0
description: Storage of blood samples
arm group label: Control
arm group type: Other
arm group label: Rheumatoid arthritis patients
arm group type: Other
intervention type: Procedure
intervention name: Blood sample
description: 2ml blood taken into TruCulture tube
arm group label: Control
arm group label: Rheumatoid arthritis patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Immune System Diseases
mesh term: Autoimmune Diseases