<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/NCT01722617</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A01349-32</org_study_id>
    <nct_id>NCT01722617</nct_id>
  </id_info>
  <brief_title>A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.</brief_title>
  <acronym>FLARE</acronym>
  <official_title>A Study to Validate Questionnaires FLARE and OM-RA-FLARE Measuring Disease Flares in Patients With Rheumatoid Arthritis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Régional et Universitaire de Brest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bichat Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Groupe Hospitalier Pitie-Salpetriere</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rheumatoid arthritis (RA) is a rheumatic inflammatory synovitis characterized by pain and&#xD;
      joint swelling as well as thickening synovial (pannus) lesions that are responsible of&#xD;
      osteocartilaginous and tendon damage. It evolves in spurts or long and variable intensity&#xD;
      interspersed with remissions.&#xD;
&#xD;
      The effectiveness of treatment is based on the proportion of patients who achieve a certain&#xD;
      degree of improvement over the initial level of various parameters such as response criteria&#xD;
      ACR 20, 50 or 70% or EULAR based on the evolution of DAS 28 or DAS 44. These response&#xD;
      criteria are now well validated but do not fully take into account the improvement of the&#xD;
      patient's condition. In contrast, there is no questionnaire to identify the proportion of&#xD;
      patients whose RA worsened between the medical visits. Such a questionnaire is necessary to&#xD;
      detect flares outbreaks in daily practice and in randomized clinical trials, follow-up&#xD;
      studies or longitudinal studies after drugs marketing to detect a reversal of disease&#xD;
      activity.&#xD;
&#xD;
      Both STPR group and OMERACT group have each developed such a new self-administered&#xD;
      questionnaire (FLARE and OM-RA-FLARE) to detect the flare- in RA patients.&#xD;
&#xD;
      The objective of this study is to validate the questionnaires FLARE and OM-RA-FLARE among RA&#xD;
      patients using the methodology advocated by the OMERACT in terms of validity (truth),&#xD;
      discriminating power (discrimination) and feasibility&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be 6 months of follow up including 3 medical visits for each patients:&#xD;
&#xD;
        -  M0 (medical visit for inclusion)&#xD;
&#xD;
        -  follow up between M0 - M3&#xD;
&#xD;
        -  M3 (medical visit at 3 months after inclusion)&#xD;
&#xD;
        -  follow up between M3 - M6&#xD;
&#xD;
        -  M6 (medical visit at 6 months after inclusion)&#xD;
&#xD;
      At the inclusion visit (M0), after the verification of inclusion and non-inclusion criteria,&#xD;
      the following information will be collected:&#xD;
&#xD;
        -  Socio-demographical data : age, sex, level of education (primary, secondary, college,&#xD;
           university), occupational category (INSEE in 6 categories)&#xD;
&#xD;
        -  Items of the ACR 1987 and ACR/EULAR 2010;&#xD;
&#xD;
        -  Length of the RA&#xD;
&#xD;
        -  Erosive or not (presence Yes / no)&#xD;
&#xD;
        -  IgM rheumatoid factor (presence Yes / No)&#xD;
&#xD;
        -  Anti CCP antbodies (presence Yes / No)&#xD;
&#xD;
      During follow-up visits (M3 and M6), the elements collected are:&#xD;
&#xD;
        1. by the study technician (TEC)&#xD;
&#xD;
             -  the inflammatory activity index, evaluated by patient (RAPID-3);&#xD;
&#xD;
             -  the functional limitations index (HAQ);&#xD;
&#xD;
             -  the PASS questionnaire;&#xD;
&#xD;
             -  the OM-RA-FLARE questionnaire;&#xD;
&#xD;
             -  the FLARE questionnaire.&#xD;
&#xD;
        2. by the doctor :&#xD;
&#xD;
             -  elements of DAS 28, this includes a blood test that will be done in the city or in&#xD;
                the hospital ;&#xD;
&#xD;
             -  the doctor's decision at the end of the consultation, in terms of :&#xD;
&#xD;
                  -  DMRADs: continuing the treatment, decreasing or increasing the dose, changing&#xD;
                     it due to its ineffectiveness, changing it due to patients' intolerance.&#xD;
&#xD;
                  -  Symptomatic treatments: continuing corticosteroids, increase the dose of&#xD;
                     corticosteroids, corticosteroid infiltration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The validity of the questionnaire FLARE.</measure>
    <time_frame>6 mois</time_frame>
    <description>The validity of the questionnaire shows the characteristics of the questionnaires (its ability to comprise the aspects for which it was designed). It will be studied by calculating the correlation coefficients between FLARE / OM-RA-FLARE on one hand, and various measures of disease activities (DAS 28, RAPID-3, RAID and AUC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The discriminating power of the instrument FLARE.</measure>
    <time_frame>6 mois.</time_frame>
    <description>The discriminating power, i.e.the degree of precision for each particular instrument, considered individually, will be assessed by its reproducibility, sensitivity to change and its impact on medical decision making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The feasibility of the questionnaire FLARE</measure>
    <time_frame>6 months.</time_frame>
    <description>The feasibility will be measured by the percentage of non-calculable scores (missing data) and the number of items that are not filled for calculable scores.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>DAS 28</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will be asked to fill basic questionnaires, but without the FLARE questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAS 28 + FLARE questionnaires</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will be asked to fill basic questionnaires and FLARE questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAS 28+FLARE + information to doctor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will fill basic and FLARE questionnaires which then will be transmitted to physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.</description>
    <arm_group_label>DAS 28 + FLARE questionnaires</arm_group_label>
    <arm_group_label>DAS 28+FLARE + information to doctor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  Having Rheumatoid Arthritis (RA) since more than 6 months, meeting the ACR 1987 and&#xD;
             the ACR / EULAR 2010;&#xD;
&#xD;
          -  Treatment of RA:&#xD;
&#xD;
               -  Treatment of disease modifying anti-rheumatic drugs (DRMADs) or biological&#xD;
                  treatment stable for more than 2 months;&#xD;
&#xD;
               -  Symptomatic treatment (including corticosteroid) stable for more than 2 months;&#xD;
&#xD;
          -  Receive the medical exam first;&#xD;
&#xD;
          -  Agreed and signed the informed consent form;&#xD;
&#xD;
          -  Ability to comply with the study protocol;&#xD;
&#xD;
          -  Having the social insurance coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing surgery during the study period;&#xD;
&#xD;
          -  Patients without any affiliation to a social security coverage (or entitled&#xD;
             beneficiary);&#xD;
&#xD;
          -  Patients under guardianship or trusteeship.&#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>Francis Guillemin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CIC-EC Inserm, CHU de Nancy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Fautrel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacques Morel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHU Hôpital Général</name>
      <address>
        <city>Dijon</city>
        <state>Bourgogne</state>
        <zip>21033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHU La Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <state>Bretagne</state>
        <zip>29607</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHRU Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <state>Bretagne</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHU Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <state>Franche-Comté</state>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHU Fort de France</name>
      <address>
        <city>Fort de France</city>
        <state>La Martinique</state>
        <zip>97261</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, Hôpitaux de Rouen</name>
      <address>
        <city>Rouen</city>
        <state>Normandie</state>
        <zip>76233</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHU - Hôpital Sud A. Michallon</name>
      <address>
        <city>Grenoble</city>
        <state>Rhône-Alpes</state>
        <zip>38130</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHU Conception</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fédération de Rhumatologie, CHU Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, APHP - CHU Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, APHP - GH Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie, Hôpital Larey</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2012</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</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/NCT01722617
org study id: 2011-A01349-32
nct id: NCT01722617
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
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has dmc: No
Rheumatoid arthritis (RA) is a rheumatic inflammatory synovitis characterized by pain and
      joint swelling as well as thickening synovial (pannus) lesions that are responsible of
      osteocartilaginous and tendon damage. It evolves in spurts or long and variable intensity
      interspersed with remissions.

      The effectiveness of treatment is based on the proportion of patients who achieve a certain
      degree of improvement over the initial level of various parameters such as response criteria
      ACR 20, 50 or 70% or EULAR based on the evolution of DAS 28 or DAS 44. These response
      criteria are now well validated but do not fully take into account the improvement of the
      patient's condition. In contrast, there is no questionnaire to identify the proportion of
      patients whose RA worsened between the medical visits. Such a questionnaire is necessary to
      detect flares outbreaks in daily practice and in randomized clinical trials, follow-up
      studies or longitudinal studies after drugs marketing to detect a reversal of disease
      activity.

      Both STPR group and OMERACT group have each developed such a new self-administered
      questionnaire (FLARE and OM-RA-FLARE) to detect the flare- in RA patients.

      The objective of this study is to validate the questionnaires FLARE and OM-RA-FLARE among RA
      patients using the methodology advocated by the OMERACT in terms of validity (truth),
      discriminating power (discrimination) and feasibility
There will be 6 months of follow up including 3 medical visits for each patients:

        -  M0 (medical visit for inclusion)

        -  follow up between M0 - M3

        -  M3 (medical visit at 3 months after inclusion)

        -  follow up between M3 - M6

        -  M6 (medical visit at 6 months after inclusion)

      At the inclusion visit (M0), after the verification of inclusion and non-inclusion criteria,
      the following information will be collected:

        -  Socio-demographical data : age, sex, level of education (primary, secondary, college,
           university), occupational category (INSEE in 6 categories)

        -  Items of the ACR 1987 and ACR/EULAR 2010;

        -  Length of the RA

        -  Erosive or not (presence Yes / no)

        -  IgM rheumatoid factor (presence Yes / No)

        -  Anti CCP antbodies (presence Yes / No)

      During follow-up visits (M3 and M6), the elements collected are:

        1. by the study technician (TEC)

             -  the inflammatory activity index, evaluated by patient (RAPID-3);

             -  the functional limitations index (HAQ);

             -  the PASS questionnaire;

             -  the OM-RA-FLARE questionnaire;

             -  the FLARE questionnaire.

        2. by the doctor :

             -  elements of DAS 28, this includes a blood test that will be done in the city or in
                the hospital ;

             -  the doctor's decision at the end of the consultation, in terms of :

                  -  DMRADs: continuing the treatment, decreasing or increasing the dose, changing
                     it due to its ineffectiveness, changing it due to patients' intolerance.

                  -  Symptomatic treatments: continuing corticosteroids, increase the dose of
                     corticosteroids, corticosteroid infiltration.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: The validity of the questionnaire FLARE.
time frame: 6 mois
description: The validity of the questionnaire shows the characteristics of the questionnaires (its ability to comprise the aspects for which it was designed). It will be studied by calculating the correlation coefficients between FLARE / OM-RA-FLARE on one hand, and various measures of disease activities (DAS 28, RAPID-3, RAID and AUC).
measure: The discriminating power of the instrument FLARE.
time frame: 6 mois.
description: The discriminating power, i.e.the degree of precision for each particular instrument, considered individually, will be assessed by its reproducibility, sensitivity to change and its impact on medical decision making.
measure: The feasibility of the questionnaire FLARE
time frame: 6 months.
description: The feasibility will be measured by the percentage of non-calculable scores (missing data) and the number of items that are not filled for calculable scores.
arm group label: DAS 28
arm group type: No Intervention
description: Patients in this group will be asked to fill basic questionnaires, but without the FLARE questionnaires.
arm group label: DAS 28 + FLARE questionnaires
arm group type: Active Comparator
description: Patients in this group will be asked to fill basic questionnaires and FLARE questionnaires.
arm group label: DAS 28+FLARE + information to doctor
arm group type: Active Comparator
description: Patients in this group will fill basic and FLARE questionnaires which then will be transmitted to physician.
intervention type: Other
intervention name: Questionnaire
description: Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.
arm group label: DAS 28 + FLARE questionnaires
arm group label: DAS 28+FLARE + information to doctor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francis Guillemin, MD, PhD
role: Principal Investigator
affiliation: CIC-EC Inserm, CHU de Nancy
last name: Bruno Fautrel, MD, PhD
role: Principal Investigator
affiliation: Service de Rhumatologie, Groupe Hospitalier Pitié - Salpêtrière, Paris
last name: Jacques Morel, MD, PhD
role: Principal Investigator
affiliation: Service d'immunorhumatologie, Hôpital Lapeyronie, Montpellier
facility: 
facility: 
facility: 
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country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid