<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/NCT03004651</url>
  </required_header>
  <id_info>
    <org_study_id>9742</org_study_id>
    <nct_id>NCT03004651</nct_id>
  </id_info>
  <brief_title>BMI and Ultrasound/Clinical Assessments of RA Disease Activity</brief_title>
  <acronym>RABODI</acronym>
  <official_title>Impact of Body Mass Index on the Agreement Between Ultrasound- and Clinical Assessments of Disease Activity in RA : Cross-sectionnal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pitié-Salpêtrière Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Ambroise Paré Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CHU Brest Hôpital La Cavale Blanche</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Purpan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Lyon Sud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier de la côte Basque</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of the level of agreement between Power Doppler ultrasound measured number of&#xD;
      synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen&#xD;
      joints in obese (i.e. BMI&gt;30) versus normally weighted RA patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical evaluation of synovitis in rheumatoid arthritis (RA) is difficult in obese and&#xD;
      overweighted patients, due to the fat pad located around the joint, that can over- or under&#xD;
      estimate the number of joints regarded as swollen by clinical examination. RA in obese and&#xD;
      overweighted patients has several distinctive characteristics as compared to the disease&#xD;
      observed in normally weighted subjects: diease activity (assessed by composites scores such&#xD;
      as Disease Activity Score (DAS28) or Simple Disease Activity Index (SDAI)) is higher, while&#xD;
      response to treatment and severity (asessed by radiographic progression) are lower.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary end point: Comparison of the level of agreement between the number of joints&#xD;
      considered abnormal by Power Doppler ultrasound synovitis (≥ grade 1 on a semi-quantitative&#xD;
      scale) and clinical examination (swollen joint count (SJC) as componant of SDAI) in obese&#xD;
      (i.e. BMI&gt;30) versus normally weighted RA patients.&#xD;
&#xD;
      Secondary end points :&#xD;
&#xD;
        -  Comparison of the level of agreement between clinical and ultrasound findings in&#xD;
           overweighted versus normally weighted patients, when joint count evaluation is based on&#xD;
           another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints,&#xD;
           and based on a joint by joint evaluation&#xD;
&#xD;
        -  Comparison of agreement between obese and non obese&#xD;
&#xD;
        -  Evaluation of the impact of other factors than BMI on the level of agreement between&#xD;
           Power Doppler ultrasound defined number of synovitis and clinically defined swollen&#xD;
           joint count&#xD;
&#xD;
        -  Reliability between Ultrasound and clinical examination across the different&#xD;
           investigation centers Study design: prospective multicenter observational study&#xD;
           Inclusion criteria: RA patients fulfilling ACR/EULAR 2010 criteria Exclusion criteria:&#xD;
           patient simultaneously included in another study with blinded treatment; Steinbrocker&#xD;
           class IV patients Outcome measure : Level of agreement between SJC and power Doppler US&#xD;
           synovitis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">February 20, 2018</completion_date>
  <primary_completion_date type="Actual">February 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the level of agreement between the number of abnormal joints and clinical evaluation</measure>
    <time_frame>18 months</time_frame>
    <description>Comparison of the level of agreement between the number of abnormal joints as defined by Power Doppler ultrasound (≥ grade 1 synovitis on a semi-quantitative scale) and clinical evaluation (swollen joint count (SJC) as componant of SDAI) in obese</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight</measure>
    <time_frame>18 months</time_frame>
    <description>Comparison of the level of agreement between clinical and ultrasound findings in overweighted versus normally weighted patients, when joint count evaluation is based on another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints, and based on a joint by joint evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam</measure>
    <time_frame>18 months</time_frame>
    <description>Evaluation of the impact of other factors than BMI on the level of agreement between Power Doppler ultrasound defined number of synovitis and clinically defined swollen joint count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of the comparison between Ultrasound and clinical examination</measure>
    <time_frame>18 months</time_frame>
    <description>Reliability between Ultrasound and clinical examination across the different investigation centers</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">121</enrollment>
  <condition>Obsessional Erotomania</condition>
  <arm_group>
    <arm_group_label>Obese Patients</arm_group_label>
    <description>Power Doppler ultrasound on obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non obese patients</arm_group_label>
    <description>Power Doppler ultrasound on non obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Power Doppler ultrasound</intervention_name>
    <description>Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)</description>
    <arm_group_label>Non obese patients</arm_group_label>
    <arm_group_label>Obese Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical evaluation</intervention_name>
    <description>swollen joint count (SJC) as componant of SDAI</description>
    <arm_group_label>Non obese patients</arm_group_label>
    <arm_group_label>Obese Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Clinical evaluation of synovitis in rheumatoid arthritis (RA) is difficult in obese and&#xD;
        overweighted patients, due to the fat pad located around the joint, that can over- or under&#xD;
        estimate the number of joints regarded as swollen by clinical examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  RA patients fulfilling ACR/EULAR 2010 criteria&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient simultaneously included in another study with blinded treatment; Steinbrocker&#xD;
             class IV patients, pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gaël MOUTERDE, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Regional Hospital Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <state>Languedoc-Roussillon</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03004651
org study id: 9742
nct id: NCT03004651
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Comparison of the level of agreement between Power Doppler ultrasound measured number of
      synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen
      joints in obese (i.e. BMI>30) versus normally weighted RA patients.
Clinical evaluation of synovitis in rheumatoid arthritis (RA) is difficult in obese and
      overweighted patients, due to the fat pad located around the joint, that can over- or under
      estimate the number of joints regarded as swollen by clinical examination. RA in obese and
      overweighted patients has several distinctive characteristics as compared to the disease
      observed in normally weighted subjects: diease activity (assessed by composites scores such
      as Disease Activity Score (DAS28) or Simple Disease Activity Index (SDAI)) is higher, while
      response to treatment and severity (asessed by radiographic progression) are lower.

      Objectives:

      Primary end point: Comparison of the level of agreement between the number of joints
      considered abnormal by Power Doppler ultrasound synovitis (≥ grade 1 on a semi-quantitative
      scale) and clinical examination (swollen joint count (SJC) as componant of SDAI) in obese
      (i.e. BMI>30) versus normally weighted RA patients.

      Secondary end points :

        -  Comparison of the level of agreement between clinical and ultrasound findings in
           overweighted versus normally weighted patients, when joint count evaluation is based on
           another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints,
           and based on a joint by joint evaluation

        -  Comparison of agreement between obese and non obese

        -  Evaluation of the impact of other factors than BMI on the level of agreement between
           Power Doppler ultrasound defined number of synovitis and clinically defined swollen
           joint count

        -  Reliability between Ultrasound and clinical examination across the different
           investigation centers Study design: prospective multicenter observational study
           Inclusion criteria: RA patients fulfilling ACR/EULAR 2010 criteria Exclusion criteria:
           patient simultaneously included in another study with blinded treatment; Steinbrocker
           class IV patients Outcome measure : Level of agreement between SJC and power Doppler US
           synovitis
observational model: Case-Control
time perspective: Prospective
measure: Comparison of the level of agreement between the number of abnormal joints and clinical evaluation
time frame: 18 months
description: Comparison of the level of agreement between the number of abnormal joints as defined by Power Doppler ultrasound (≥ grade 1 synovitis on a semi-quantitative scale) and clinical evaluation (swollen joint count (SJC) as componant of SDAI) in obese
measure: Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight
time frame: 18 months
description: Comparison of the level of agreement between clinical and ultrasound findings in overweighted versus normally weighted patients, when joint count evaluation is based on another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints, and based on a joint by joint evaluation
measure: Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam
time frame: 18 months
description: Evaluation of the impact of other factors than BMI on the level of agreement between Power Doppler ultrasound defined number of synovitis and clinically defined swollen joint count
measure: Reproducibility of the comparison between Ultrasound and clinical examination
time frame: 18 months
description: Reliability between Ultrasound and clinical examination across the different investigation centers
arm group label: Obese Patients
description: Power Doppler ultrasound on obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)
arm group label: Non obese patients
description: Power Doppler ultrasound on non obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)
intervention type: Other
intervention name: Power Doppler ultrasound
description: Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)
arm group label: Non obese patients
arm group label: Obese Patients
intervention type: Other
intervention name: Clinical evaluation
description: swollen joint count (SJC) as componant of SDAI
arm group label: Non obese patients
arm group label: Obese Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gaël MOUTERDE, PH
role: Principal Investigator
affiliation: CHU de Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No