xml: <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/NCT06004817</url>
    </required_header>
    <id_info>
      <org_study_id>2023PI150</org_study_id>
      <nct_id>NCT06004817</nct_id>
    </id_info>
    <brief_title>Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis</brief_title>
    <acronym>JADE</acronym>
    <official_title>Evaluation of Severity in Juvenile Dermatomyositis and Adult-onset Dermatomyositis: a National Multicentric Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Central Hospital, Nancy, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Central Hospital, Nancy, 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) are rare and heterogeneous systemic autoimmune diseases, characterized&#xD;
        by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern&#xD;
        both adults and children. DM can be life-threatening (interstitial lung disease, infectious&#xD;
        complications) and responsible of significant functional disability (muscle weakness). Age of&#xD;
        onset appear to be an independent prognostic factor. Juvenile-onset DM is characterized by a&#xD;
        higher frequency of calcinosis, skin ulceration and digestive vasculitis. In adults,&#xD;
        interstitial lung disease and cancer are more frequent with higher mortality. Data concerning&#xD;
        the comparison of the initial severity between juvenile and adult-onset DM are limited.&#xD;
  &#xD;
        The main objective is to compare global severity between juvenile DM and adult-onset DM at&#xD;
        initial diagnosis.&#xD;
  &#xD;
        Secondary objectives are:&#xD;
  &#xD;
          -  to compare organ-specific severity between juvenile DM and adult-onset DM at diagnosis.&#xD;
  &#xD;
          -  to compare damage during follow-up and at last follow-up between juvenile DM and&#xD;
             adult-onset DM.&#xD;
  &#xD;
          -  to compare activity at the last follow-up between juvenile DM and adult-onset DM.&#xD;
  &#xD;
          -  to compare iatrogenic complications between juvenile DM and adult-onset DM.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>number of patients with global severity</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>presence of at least one criteria among: severe muscle disease (Childhood Myositis Assessment Scale&#xD;
  - CMAS - score &lt; 15, and/or Manual Muscle Testing 8 - MMT8 - score &lt; 30, and/or Medical Research Council - MRC - muscle testing &lt; 3, and/or dysphagia and/or swallowing difficulties), symptomatic interstitial lung disease (ILD), digestive vasculitis (digestive bleeding and/or vasculitis on CT-scan), myocarditis on cardiac MRI, severe skin ulcerations, intensive care unit admission</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>number of patients with muscular severity</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>presence of at least one of the following criteria: CMAS score &lt; 15, MMT8 score &lt; 30, MRC muscle testing &lt; 3, dysphagia, swallowing difficulties</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of patients with pulmonary severity</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>presence of symptomatic ILD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of patients with digestive severity</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>presence of digestive vasculitis: digestive bleeding and/or vasculitis on CT-scan</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of patients with cutaneous severity</measure>
      <time_frame>baseline (J0)</time_frame>
      <description>presence of severe skin ulcerations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>myositis damage index (MDI) score</measure>
      <time_frame>2 years of follow-up, at 5 years of follow-up and at last follow-up</time_frame>
      <description>myositis damage index (MDI) extent of damage score: from 0 (better outcome) to 38 (worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of patients with remission at last follow-up</measure>
      <time_frame>up to 10 years</time_frame>
      <description>absence of disease activity without any immunosuppressive/immunomodulatory treatment for at least 2 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of patients with disease activity at last follow-up</measure>
      <time_frame>up to 10 years</time_frame>
      <description>presence of at least one of the following criteria: elevated creatinine kinase (CK) level and/or recent muscle testing deterioration and/or muscle inflammation on MRI, and/or skin manifestations and/or progressive ILD</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Dermatomyositis</condition>
    <arm_group>
      <arm_group_label>Juvenile dermatomyositis</arm_group_label>
      <description>Dermatomyositis before 18 years-old</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Adult-onset dermatomyositis</arm_group_label>
      <description>Dermatomyositis from 18 years-old</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>evaluation of clinical severity</intervention_name>
      <description>evaluation of clinical severity</description>
      <arm_group_label>Adult-onset dermatomyositis</arm_group_label>
      <arm_group_label>Juvenile dermatomyositis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients followed in pediatric and adult units during January 2010 and December 2022&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with dermatomyositis according to 2017 American College of Rheumatology (ACR)/&#xD;
               European Alliance of Associations for Rheumatology (EULAR) classification&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with cancer-associated dermatomyositis (within 3 years before or after&#xD;
               diagnosis of dermatomyositis)&#xD;
  &#xD;
            -  Patient with antisynthetase syndrome&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Paul Decker, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Nancy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paul Decker, MD</last_name>
      <phone>+33383157240</phone>
      <email>p.decker@chru-nancy.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
      <investigator_full_name>Paul DECKER, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </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>
  
  
text: 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/NCT06004817
  org study id: 2023PI150
  nct id: NCT06004817
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Dermatomyositis (DM) are rare and heterogeneous systemic autoimmune diseases, characterized
        by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern
        both adults and children. DM can be life-threatening (interstitial lung disease, infectious
        complications) and responsible of significant functional disability (muscle weakness). Age of
        onset appear to be an independent prognostic factor. Juvenile-onset DM is characterized by a
        higher frequency of calcinosis, skin ulceration and digestive vasculitis. In adults,
        interstitial lung disease and cancer are more frequent with higher mortality. Data concerning
        the comparison of the initial severity between juvenile and adult-onset DM are limited.
  
        The main objective is to compare global severity between juvenile DM and adult-onset DM at
        initial diagnosis.
  
        Secondary objectives are:
  
          -  to compare organ-specific severity between juvenile DM and adult-onset DM at diagnosis.
  
          -  to compare damage during follow-up and at last follow-up between juvenile DM and
             adult-onset DM.
  
          -  to compare activity at the last follow-up between juvenile DM and adult-onset DM.
  
          -  to compare iatrogenic complications between juvenile DM and adult-onset DM.
  observational model: Cohort
  time perspective: Retrospective
  measure: number of patients with global severity
  time frame: baseline (J0)
  description: presence of at least one criteria among: severe muscle disease (Childhood Myositis Assessment Scale
  - CMAS - score < 15, and/or Manual Muscle Testing 8 - MMT8 - score < 30, and/or Medical Research Council - MRC - muscle testing < 3, and/or dysphagia and/or swallowing difficulties), symptomatic interstitial lung disease (ILD), digestive vasculitis (digestive bleeding and/or vasculitis on CT-scan), myocarditis on cardiac MRI, severe skin ulcerations, intensive care unit admission
  measure: number of patients with muscular severity
  time frame: baseline (J0)
  description: presence of at least one of the following criteria: CMAS score < 15, MMT8 score < 30, MRC muscle testing < 3, dysphagia, swallowing difficulties
  measure: number of patients with pulmonary severity
  time frame: baseline (J0)
  description: presence of symptomatic ILD
  measure: number of patients with digestive severity
  time frame: baseline (J0)
  description: presence of digestive vasculitis: digestive bleeding and/or vasculitis on CT-scan
  measure: number of patients with cutaneous severity
  time frame: baseline (J0)
  description: presence of severe skin ulcerations
  measure: myositis damage index (MDI) score
  time frame: 2 years of follow-up, at 5 years of follow-up and at last follow-up
  description: myositis damage index (MDI) extent of damage score: from 0 (better outcome) to 38 (worse outcome)
  measure: number of patients with remission at last follow-up
  time frame: up to 10 years
  description: absence of disease activity without any immunosuppressive/immunomodulatory treatment for at least 2 years
  measure: number of patients with disease activity at last follow-up
  time frame: up to 10 years
  description: presence of at least one of the following criteria: elevated creatinine kinase (CK) level and/or recent muscle testing deterioration and/or muscle inflammation on MRI, and/or skin manifestations and/or progressive ILD
  arm group label: Juvenile dermatomyositis
  description: Dermatomyositis before 18 years-old
  arm group label: Adult-onset dermatomyositis
  description: Dermatomyositis from 18 years-old
  intervention type: Other
  intervention name: evaluation of clinical severity
  description: evaluation of clinical severity
  arm group label: Adult-onset dermatomyositis
  arm group label: Juvenile dermatomyositis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Paul Decker, MD
  role: Principal Investigator
  affiliation: CHU Nancy
  last name: Paul Decker, MD
  phone: +33383157240
  email: p.decker@chru-nancy.fr
  responsible party type: Principal Investigator
  investigator affiliation: Central Hospital, Nancy, France
  investigator full name: Paul DECKER, MD
  investigator title: Principal Investigator
  mesh term: Dermatomyositis
  sharing ipd: No