<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/NCT03302442</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0471</org_study_id>
    <nct_id>NCT03302442</nct_id>
  </id_info>
  <brief_title>Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis</brief_title>
  <acronym>COMP-RMS</acronym>
  <official_title>Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide&#xD;
      on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis&#xD;
      (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 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>Relapse within first year of treatment</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of patients experimenting at least one relapse within the first year of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of clinical event at Two years</measure>
    <time_frame>24 months</time_frame>
    <description>Proportion of patients with at least one relapse at two years of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of disability</measure>
    <time_frame>12 months and 24 months</time_frame>
    <description>Proportion of patients with a progression of disability defined by any increased of EDSS score compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological disease activity</measure>
    <time_frame>12 months and 24 months</time_frame>
    <description>Proportion of patients with at least one Gd-enhancing lesion and the proportion of patients with at least one new T2-lesion on MRI scans compared to baseline MRI scan Probablity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse drug reaction</measure>
    <time_frame>12 months and 24 months</time_frame>
    <description>Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR</description>
  </secondary_outcome>
  <enrollment type="Actual">3000</enrollment>
  <condition>Relapsing-remitting Multiple Sclerosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non interventional study</intervention_name>
    <description>Not applicable - Non interventional Study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        RRMS Patients who initiated either DMF or Teriflunomide and with an available MRI scan and&#xD;
        EDSS assessment respectively within 12 and 6 months before treatment initiation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RRMS Patients with an EDSS score ranging between 0 and 5.5, who initiated either DMF&#xD;
             or Teriflunomide before 1/01/2016 and with an available MRI scan and EDSS assessment&#xD;
             respectively within 12 and 6 months before treatment initiation Patients who had&#xD;
             consent to OFSEP registry Naive patient or treated with prior first line treatment :&#xD;
             interferon, glatiramer acetate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with progressive multiple sclerosis&#xD;
&#xD;
          -  Patients with prior second line Patient with no MRI or EDSS score within the year&#xD;
             before DMF or Teriflunomide initiation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</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>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</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/NCT03302442
org study id: RC16_0471
nct id: NCT03302442
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide
      on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis
      (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )
observational model: Cohort
time perspective: Retrospective
measure: Relapse within first year of treatment
time frame: 12 months
description: Proportion of patients experimenting at least one relapse within the first year of treatment
measure: Occurrence of clinical event at Two years
time frame: 24 months
description: Proportion of patients with at least one relapse at two years of treatment
measure: Progression of disability
time frame: 12 months and 24 months
description: Proportion of patients with a progression of disability defined by any increased of EDSS score compared to baseline
measure: Radiological disease activity
time frame: 12 months and 24 months
description: Proportion of patients with at least one Gd-enhancing lesion and the proportion of patients with at least one new T2-lesion on MRI scans compared to baseline MRI scan Probablity
measure: Adverse drug reaction
time frame: 12 months and 24 months
description: Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR
intervention type: Other
intervention name: Non interventional study
description: Not applicable - Non interventional Study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
sharing ipd: No