<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/NCT02969304</url>
  </required_header>
  <id_info>
    <org_study_id>109MS409</org_study_id>
    <nct_id>NCT02969304</nct_id>
  </id_info>
  <brief_title>Study of Utilization Patterns of Dimethyl Fumarate in Germany</brief_title>
  <official_title>Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biogen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to estimate the proportion of DMF use that is&#xD;
      prescribed &quot;on-label&quot; versus &quot;off-label&quot;. The secondary objectives are: To describe the&#xD;
      demographic characteristics and medical history of DMF users; To describe prescription drug&#xD;
      history and concomitant medication use of DMF users; To describe the duration of therapy in&#xD;
      participants newly initiating DMF treatment; To describe the medical specialties of DMF&#xD;
      prescribers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dimethyl fumarate will not be provided to participants as a part of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2016</start_date>
  <completion_date type="Actual">March 2, 2017</completion_date>
  <primary_completion_date type="Actual">March 2, 2017</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>Proportion of dimethyl fumarate use that is prescribed &quot;on-label&quot; versus &quot;off-label&quot; in Germany</measure>
    <time_frame>Up to 18 months after market introduction of dimethyl fumarate in Germany</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of dimethyl fumarate users</measure>
    <time_frame>Up to 18 months after market introduction of dimethyl fumarate in Germany</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescription drug history of dimethyl fumarate users</measure>
    <time_frame>Up to 18 months after market introduction of dimethyl fumarate in Germany</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of therapy in participants newly initiating dimethyl fumarate treatment</measure>
    <time_frame>Up to 18 months after market introduction of dimethyl fumarate in Germany</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.</measure>
    <time_frame>Up to 18 months after market introduction of dimethyl fumarate in Germany</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical history of dimethyl fumarate users</measure>
    <time_frame>Up to 18 months after market introduction of dimethyl fumarate in Germany</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant medication use of dimethyl fumarate users</measure>
    <time_frame>Up to 18 months after market introduction of dimethyl fumarate in Germany</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">930</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Off-Label</arm_group_label>
    <description>Any DMF prescription for MS patients &lt;18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>On-Label</arm_group_label>
    <description>Prescriptions for patients who are ≥18 years of age and diagnosed with MS</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dimethyl fumarate</intervention_name>
    <description>Off-Label Use: All participants &lt;18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate&#xD;
On-Label Use: All participants &gt;18 years of age with an MS diagnosis who are prescribed dimethyl fumarate</description>
    <arm_group_label>Off-Label</arm_group_label>
    <arm_group_label>On-Label</arm_group_label>
    <other_name>Tecfidera, DMF, BG00012</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective analysis of a research database, which contains German sick fund claims, to&#xD;
        assess the usage of dimethyl fumarate in Germany. The research database is comprised of&#xD;
        German sick fund data, which is compiled by Gesundheitsforen Leipzig (GFL). This GFL&#xD;
        database currently contains sick fund claims data for approximately 4 million patients,&#xD;
        which accounts for approximately 5-6% of the total sick fund population in Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  New users of dimethyl fumarate will be included in the analysis&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Patients for which data is not available for the 6 months period prior to the index&#xD;
             date (baseline observational period)&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Biogen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tecfidera</keyword>
  <keyword>Off-label</keyword>
  <keyword>Utilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dimethyl Fumarate</mesh_term>
  </intervention_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/NCT02969304
org study id: 109MS409
nct id: NCT02969304
lead sponsor: 
has dmc: No
The primary objective of this study is to estimate the proportion of DMF use that is
      prescribed "on-label" versus "off-label". The secondary objectives are: To describe the
      demographic characteristics and medical history of DMF users; To describe prescription drug
      history and concomitant medication use of DMF users; To describe the duration of therapy in
      participants newly initiating DMF treatment; To describe the medical specialties of DMF
      prescribers.
Dimethyl fumarate will not be provided to participants as a part of this study.
observational model: Cohort
time perspective: Retrospective
measure: Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany
time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Demographic characteristics of dimethyl fumarate users
time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Prescription drug history of dimethyl fumarate users
time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Duration of therapy in participants newly initiating dimethyl fumarate treatment
time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.
time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Medical history of dimethyl fumarate users
time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Concomitant medication use of dimethyl fumarate users
time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany
arm group label: Off-Label
description: Any DMF prescription for MS patients <18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.
arm group label: On-Label
description: Prescriptions for patients who are ≥18 years of age and diagnosed with MS
intervention type: Drug
intervention name: dimethyl fumarate
description: Off-Label Use: All participants <18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate
On-Label Use: All participants >18 years of age with an MS diagnosis who are prescribed dimethyl fumarate
arm group label: Off-Label
arm group label: On-Label
other name: Tecfidera, DMF, BG00012
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Biogen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Dimethyl Fumarate