<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/NCT03293615</url>
  </required_header>
  <id_info>
    <org_study_id>6431</org_study_id>
    <nct_id>NCT03293615</nct_id>
  </id_info>
  <brief_title>Exercise Capacity of Patients With Dermatomyosis</brief_title>
  <acronym>MIDE</acronym>
  <official_title>Exercise Capacity of Patients With Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which&#xD;
      are associated with poor health status and increased mortality. The origin of this muscle&#xD;
      impairment remains unknown.&#xD;
&#xD;
      The investigators hypothesize that mitochondria functioning is impaired in DM muscle and&#xD;
      links with exercise capacities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 28, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.</measure>
    <time_frame>Baseline</time_frame>
    <description>This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Dermatomyositis</condition>
  <arm_group>
    <arm_group_label>Dermatomyositis (DM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with dermatomyositis according to ENMC criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-dermatomyositis inflammatory myopathies</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No myopathy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients without myopathy on muscle biopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exploration</intervention_name>
    <description>Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.</description>
    <arm_group_label>Dermatomyositis (DM)</arm_group_label>
    <arm_group_label>Non-dermatomyositis inflammatory myopathies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman or man&gt; 18 years,&#xD;
&#xD;
          -  Signature of informed consent,&#xD;
&#xD;
          -  Muscle biopsy for suspicion of recent inflammatory myopathy (&lt;6 months) or for&#xD;
             exclusion of neuromuscular pathology.&#xD;
&#xD;
        Prospectively, following the results of the muscle biopsy, the subjects will divided into&#xD;
        three groups meeting the following criteria:&#xD;
&#xD;
          -  &quot;DM&quot; group: DM according to the ENMC criteria;&#xD;
&#xD;
          -  &quot;other inflammatory myopathy&quot; group: polymyositis, autoimmune necrotizing myopathy,&#xD;
             non-specific myositis or inclusion myositis according to the ENMC criteria;&#xD;
&#xD;
          -  Group &quot;no neuromuscular pathology&quot;: i) myalgia and / or intolerance to exercise and&#xD;
             ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level,&#xD;
             iv) absence of electromyographic abnormality, v) histological Muscle mass.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Taking an immunomodulatory treatment within 6 months before inclusion,&#xD;
&#xD;
          -  Paraneoplastic form of the disease,&#xD;
&#xD;
          -  Presence of associated interstitial pneumonitis,&#xD;
&#xD;
          -  Neuromuscular pathology different from inflammatory myopathy,&#xD;
&#xD;
          -  Unbalanced cardiovascular disease,&#xD;
&#xD;
          -  Impossibility of giving the subject informed information (subject in an emergency&#xD;
             situation, difficulty in understanding the subject, ...),&#xD;
&#xD;
          -  Subject under safeguard of justice,&#xD;
&#xD;
          -  Subject under tutelage or under curators,&#xD;
&#xD;
          -  Pregnancy (positive pregnancy test)&#xD;
&#xD;
          -  Breastfeeding.&#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>Alain Meyer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Les Hôpitaux Universitaires de Strasbourg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alain Meyer, MD</last_name>
    <phone>00333 6 76 95 31 67</phone>
    <email>alain.meyer1@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meyer</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</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>Dermatomyositis</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/NCT03293615
org study id: 6431
nct id: NCT03293615
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which
      are associated with poor health status and increased mortality. The origin of this muscle
      impairment remains unknown.

      The investigators hypothesize that mitochondria functioning is impaired in DM muscle and
      links with exercise capacities.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.
time frame: Baseline
description: This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy
arm group label: Dermatomyositis (DM)
arm group type: Experimental
description: Patients with dermatomyositis according to ENMC criteria
arm group label: Non-dermatomyositis inflammatory myopathies
arm group type: Active Comparator
description: Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria
arm group label: No myopathy
arm group type: No Intervention
description: Patients without myopathy on muscle biopsy
intervention type: Other
intervention name: exploration
description: Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.
arm group label: Dermatomyositis (DM)
arm group label: Non-dermatomyositis inflammatory myopathies
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alain Meyer
role: Principal Investigator
affiliation: Les Hôpitaux Universitaires de Strasbourg
last name: Alain Meyer, MD
phone: 00333 6 76 95 31 67
email: alain.meyer1@chru-strasbourg.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Dermatomyositis
sharing ipd: No