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/NCT05964946</url>
    </required_header>
    <id_info>
      <org_study_id>CACZ885HFR01</org_study_id>
      <nct_id>NCT05964946</nct_id>
    </id_info>
    <brief_title>Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France</brief_title>
    <official_title>Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted&#xD;
        on the National Health Data System (Système National des Données de Santé, SNDS).&#xD;
  &#xD;
        The study did not modify the doctor-patient relationship, nor the management or follow-up of&#xD;
        patients. Patients with dispensation of canakinumab for gouty arthritis were selected over&#xD;
        the period from 08 April 2018 to 07 April 2020; index date was defined as date of the first&#xD;
        dispensation of canakinumab in community pharmacy during study period.&#xD;
  &#xD;
        Patients were described at index date. Medical history and comorbidities, and previous&#xD;
        treatments for gouty arthritis were assessed during 3 years prior to index date.&#xD;
        Co-treatments of interest for which standard treatments for gouty arthritis were&#xD;
        contraindicated or required precautions for use were assessed during 6 months prior to index&#xD;
        date.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 24, 2020</start_date>
    <completion_date type="Actual">July 29, 2022</completion_date>
    <primary_completion_date type="Actual">July 29, 2022</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 treated with canakinumab in France for the treatment of gouty arthritis</measure>
      <time_frame>2 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean age of patients</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of male patients</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geographic location of patients</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with previous treatments for gouty arthritis</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical history of patients</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with comorbidities</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <enrollment type="Actual">15</enrollment>
    <condition>Gouty Arthritis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          This was a retrospective, noninterventional cohort study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Received at least one reimbursement of Ilaris® from 08 April 2018 to 07 April 2020.&#xD;
  &#xD;
            -  Benefited from at least one of the following healthcare consumptions during 3 years&#xD;
               prior to index date:&#xD;
  &#xD;
               o At least one hospitalization with a main diagnosis or a related diagnosis in a&#xD;
               Medical Unit Summary or a significant associated diagnosis in a Standardized Discharge&#xD;
               Summary corresponding to the International Classification of Diseases, 10th Revision&#xD;
               (ICD-10) code:&#xD;
  &#xD;
                 -  M10.0 &quot;Idiopathic gout&quot;&#xD;
  &#xD;
                 -  M10.1 &quot;Saturnine gout&quot;&#xD;
  &#xD;
                 -  M10.2 &quot;Medicated gout&quot;&#xD;
  &#xD;
                 -  M10.3 &quot;Gout due to impaired renal function&quot;&#xD;
  &#xD;
                 -  M10.4 &quot;Other secondary gout&quot;&#xD;
  &#xD;
                 -  M10.9 &quot;Gout, unspecified&quot;&#xD;
  &#xD;
            -  And/or an active long-term disease (Affection Longue Durée, ALD) with an ICD-10 code:&#xD;
               &quot;M10 Gout&quot;&#xD;
  &#xD;
            -  And/or at least one dispensation of colchicine and urate-lowering therapy (allopurinol&#xD;
               and/or febuxostat and/or benzbromarone and/or probenecid) at any time.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Novartis</name>
        <address>
          <city>Paris</city>
          <zip>92506</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 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>Arthritis</mesh_term>
      <mesh_term>Arthritis, Gouty</mesh_term>
    </condition_browse>
    <!-- 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/NCT05964946
  org study id: CACZ885HFR01
  nct id: NCT05964946
  lead sponsor: 
  This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted
        on the National Health Data System (Système National des Données de Santé, SNDS).
  
        The study did not modify the doctor-patient relationship, nor the management or follow-up of
        patients. Patients with dispensation of canakinumab for gouty arthritis were selected over
        the period from 08 April 2018 to 07 April 2020; index date was defined as date of the first
        dispensation of canakinumab in community pharmacy during study period.
  
        Patients were described at index date. Medical history and comorbidities, and previous
        treatments for gouty arthritis were assessed during 3 years prior to index date.
        Co-treatments of interest for which standard treatments for gouty arthritis were
        contraindicated or required precautions for use were assessed during 6 months prior to index
        date.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of patients treated with canakinumab in France for the treatment of gouty arthritis
  time frame: 2 years
  measure: Mean age of patients
  time frame: 3 years
  measure: Number of male patients
  time frame: 3 years
  measure: Geographic location of patients
  time frame: 3 years
  measure: Number of patients with previous treatments for gouty arthritis
  time frame: 3 years
  measure: Medical history of patients
  time frame: 3 years
  measure: Number of patients with comorbidities
  time frame: 3 years
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Arthritis, Gouty