<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/NCT01706029</url>
  </required_header>
  <id_info>
    <org_study_id>I11013/</org_study_id>
    <nct_id>NCT01706029</nct_id>
  </id_info>
  <brief_title>Pain Evaluation in Rheumatoid Arthritis</brief_title>
  <acronym>Douleur-PR</acronym>
  <official_title>Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the&#xD;
      priority domain of improvement for the patients instead a good control of the inflammatory&#xD;
      disease by treatments, even biotherapeutics .&#xD;
&#xD;
      Some studies show that less than 50 % of the patients is satisfied by the care of the pain,&#xD;
      whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a&#xD;
      complex and multifactorial subjective phenomenon requiring a multidimensional evaluation,&#xD;
      while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain&#xD;
      in a single dimension that is the pain intensity.&#xD;
&#xD;
      So, the investigators do not arrange explanation for this observed dichotomy between the&#xD;
      improvement of the clinical and biological inflammatory criteria of the RA and on the other&#xD;
      hand the persistence of pain.&#xD;
&#xD;
      On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the&#xD;
      physiopathology of RA and probably in the pain processing according to recent data of the&#xD;
      literature.&#xD;
&#xD;
      The aim of this study is:&#xD;
&#xD;
        -  to assess the multidimensional origin of the pain in RA patients by means of&#xD;
           questionnaires&#xD;
&#xD;
        -  to look for a possible correlation between the serum level of cytokines and pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 12, 2017</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the pain</measure>
    <time_frame>At day 1</time_frame>
    <description>Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients pain care</measure>
    <time_frame>At day 1</time_frame>
    <description>Estimate the satisfaction of the patients towards the coverage (care) of their pain by means of VAS and verbal scale of satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation</measure>
    <time_frame>At day 1</time_frame>
    <description>Estimate the correlation between the activity of the RA and the multidimensional evaluation of pain using DAS28 questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sampling of blood for dosage of IL-6, IL-17 and IL-33 serum level&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are selected from those coming to the Department of Rheumatology of each&#xD;
        partcipating center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with RA treated with DMARDs and/or biotherapy,&#xD;
&#xD;
          -  Capable of providing written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients affected by a painful disease other one than RA,&#xD;
&#xD;
          -  Fibromyalgia,&#xD;
&#xD;
          -  A malignancy disease,&#xD;
&#xD;
          -  An hemopathy,&#xD;
&#xD;
          -  Psychiatric disorders or dementia and&#xD;
&#xD;
          -  Acute infectious diseases and&#xD;
&#xD;
          -  Receive or had received anti-IL6 therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascale Vergne-Salle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Limoges</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Bordeaux- Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hôpital R. Salengro</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie</name>
      <address>
        <city>Limoges</city>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hôtel-Dieu</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bois-Guillaume</name>
      <address>
        <city>Rouen</city>
        <zip>76230</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT01706029
org study id: I11013/
nct id: NCT01706029
lead sponsor: 
has dmc: No
Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the
      priority domain of improvement for the patients instead a good control of the inflammatory
      disease by treatments, even biotherapeutics .

      Some studies show that less than 50 % of the patients is satisfied by the care of the pain,
      whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a
      complex and multifactorial subjective phenomenon requiring a multidimensional evaluation,
      while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain
      in a single dimension that is the pain intensity.

      So, the investigators do not arrange explanation for this observed dichotomy between the
      improvement of the clinical and biological inflammatory criteria of the RA and on the other
      hand the persistence of pain.

      On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the
      physiopathology of RA and probably in the pain processing according to recent data of the
      literature.

      The aim of this study is:

        -  to assess the multidimensional origin of the pain in RA patients by means of
           questionnaires

        -  to look for a possible correlation between the serum level of cytokines and pain.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the pain
time frame: At day 1
description: Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria
measure: Patients pain care
time frame: At day 1
description: Estimate the satisfaction of the patients towards the coverage (care) of their pain by means of VAS and verbal scale of satisfaction
measure: Correlation
time frame: At day 1
description: Estimate the correlation between the activity of the RA and the multidimensional evaluation of pain using DAS28 questionnaire
Sampling of blood for dosage of IL-6, IL-17 and IL-33 serum level
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascale Vergne-Salle, MD
role: Principal Investigator
affiliation: CHU Limoges
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid