<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/NCT01706055</url>
  </required_header>
  <id_info>
    <org_study_id>16400</org_study_id>
    <secondary_id>BF1213PL</secondary_id>
    <nct_id>NCT01706055</nct_id>
  </id_info>
  <brief_title>Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)</brief_title>
  <acronym>INFLUENCE</acronym>
  <official_title>Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be prospective, multicentre, observational study. Patients who will initiate&#xD;
      treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0)&#xD;
      i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient&#xD;
      demographics, medical history data, safety parameters, presence of flu-like symptoms and&#xD;
      measures to prevent or treat these symptoms will be collected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MS patient with Flu-Like Symptoms (FLS) demographic profile</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The impact of FLS on patients daily activities as measured by current professional/educational status</measure>
    <time_frame>From baseline up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">629</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Interferon beta-1b (Betaseron, BAY86-5046)</intervention_name>
    <description>Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult MS patients starting Betaferon therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald&#xD;
             (2005) criteria&#xD;
&#xD;
          -  Age &gt;/= 18 years old&#xD;
&#xD;
          -  Treatment MS patients in whom the attending physician has decided to initiate therapy&#xD;
             with interferon beta-1b; Betaferon&#xD;
&#xD;
          -  Minimum 6 months wash-out period from previous IFNβ&#xD;
&#xD;
          -  Written Informed Consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients previously treated with any of the disease modifying drugs (DMDs), with the&#xD;
             exception of IFNβ therapy which ended at least 6 months earlier&#xD;
&#xD;
          -  Patients receiving treatment with IFN beta other than Betaferon (Bayer)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis (MS)</keyword>
  <keyword>Interferon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-beta</mesh_term>
    <mesh_term>Interferon beta-1b</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/NCT01706055
org study id: 16400
secondary id: BF1213PL
nct id: NCT01706055
lead sponsor: 
has dmc: No
This will be prospective, multicentre, observational study. Patients who will initiate
      treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0)
      i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient
      demographics, medical history data, safety parameters, presence of flu-like symptoms and
      measures to prevent or treat these symptoms will be collected.
observational model: Cohort
time perspective: Prospective
measure: Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
time frame: 6 months
measure: MS patient with Flu-Like Symptoms (FLS) demographic profile
time frame: Up to 1 month
description: For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.
measure: Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS
time frame: 6 months
measure: The impact of FLS on patients daily activities as measured by current professional/educational status
time frame: From baseline up to 6 months
measure: Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period
time frame: 6 months
arm group label: Group 1
intervention type: Biological
intervention name: Interferon beta-1b (Betaseron, BAY86-5046)
description: Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Interferons
mesh term: Interferon-beta
mesh term: Interferon beta-1b