<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/NCT03029897</url>
  </required_header>
  <id_info>
    <org_study_id>16-135</org_study_id>
    <nct_id>NCT03029897</nct_id>
  </id_info>
  <brief_title>E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis</brief_title>
  <acronym>VigiP-SEP</acronym>
  <official_title>Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</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>
      Adverse drug reactions are collected exhaustively during the experimental development phase&#xD;
      of the drug, but the trial population is not representative. In post-marketing authorization,&#xD;
      the use in the real life of medicines requires to specify the profile of adverse effects&#xD;
      through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug&#xD;
      reactions prevents a satisfactory knowledge of the risks. For example, in the multiple&#xD;
      sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported&#xD;
      by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera®&#xD;
      dimethyl-fumarate, while trials reported 39% of flush.&#xD;
&#xD;
      The investigators propose a study measuring the impact of the deployment of e-reporting to&#xD;
      patients in a population suffering from multiple sclerosis in initiation of first line drug&#xD;
      therapy. The study design will be a randomized controlled trial. Twenty-four direct or&#xD;
      indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without&#xD;
      intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal&#xD;
      neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5&#xD;
      patients, a total of 180 patients will be included. The expected duration of this study is 12&#xD;
      months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient.&#xD;
      At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be&#xD;
      made by telephone call to each patient.&#xD;
&#xD;
      The study is part of the pharmacovigilance system in place in France and aims to improve its&#xD;
      efficiency by increasing declarations and therefore earlier detection of signals in order to&#xD;
      prevent and minimize risks.&#xD;
&#xD;
      The comparison of the two arms should make it possible to decide on the usefulness of&#xD;
      national support for e-reporting, while respecting a good integration with the French&#xD;
      pharmacovigilance system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">April 24, 2019</completion_date>
  <primary_completion_date type="Actual">April 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>clusters</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of reports of adverse drug reactions</measure>
    <time_frame>6 months</time_frame>
    <description>number of reports of adverse drug reactions per patient in the intervention arm using mobile versus standard arm.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are educated on the use of a mobile application to report adverse drug reactions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients are not educated on the use of a mobile application to report adverse drug reactions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>My eReport France</intervention_name>
    <description>patients are educated to the use of &quot;My eReport France&quot; application</description>
    <arm_group_label>experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient (&gt; 18 years) with relapsing-remitting multiple sclerosis. Initiation of treatment&#xD;
        of 1st line: interferon β, peginterferon β, glatiramer acetate, teriflunomide,&#xD;
        dimethyl-fumarate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient with progressively progressive secondary or multiple sclerosis. Patient suffering&#xD;
        from multiple sclerosis not treated with a first line treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Caen</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</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>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</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/NCT03029897
org study id: 16-135
nct id: NCT03029897
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adverse drug reactions are collected exhaustively during the experimental development phase
      of the drug, but the trial population is not representative. In post-marketing authorization,
      the use in the real life of medicines requires to specify the profile of adverse effects
      through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug
      reactions prevents a satisfactory knowledge of the risks. For example, in the multiple
      sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported
      by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera®
      dimethyl-fumarate, while trials reported 39% of flush.

      The investigators propose a study measuring the impact of the deployment of e-reporting to
      patients in a population suffering from multiple sclerosis in initiation of first line drug
      therapy. The study design will be a randomized controlled trial. Twenty-four direct or
      indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without
      intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal
      neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5
      patients, a total of 180 patients will be included. The expected duration of this study is 12
      months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient.
      At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be
      made by telephone call to each patient.

      The study is part of the pharmacovigilance system in place in France and aims to improve its
      efficiency by increasing declarations and therefore earlier detection of signals in order to
      prevent and minimize risks.

      The comparison of the two arms should make it possible to decide on the usefulness of
      national support for e-reporting, while respecting a good integration with the French
      pharmacovigilance system.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: clusters
primary purpose: Other
masking: None (Open Label)
measure: number of reports of adverse drug reactions
time frame: 6 months
description: number of reports of adverse drug reactions per patient in the intervention arm using mobile versus standard arm.
arm group label: experimental
arm group type: Experimental
description: Patients are educated on the use of a mobile application to report adverse drug reactions
arm group label: control
arm group type: No Intervention
description: Patients are not educated on the use of a mobile application to report adverse drug reactions
intervention type: Other
intervention name: My eReport France
description: patients are educated to the use of "My eReport France" application
arm group label: experimental
criteria: 
gender: All
minimum age: 18 Years
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
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: No