<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/NCT02247310</url>
  </required_header>
  <id_info>
    <org_study_id>17591</org_study_id>
    <secondary_id>BF1401</secondary_id>
    <nct_id>NCT02247310</nct_id>
  </id_info>
  <brief_title>BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon</brief_title>
  <official_title>BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated 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>
      Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as&#xD;
      well as the challenge to achieve high adherence to treatment, evaluating the benefits of any&#xD;
      new measure to improve adherence is important. The data storage capabilities of the&#xD;
      BETACONNECT device, including the automated recording of injections, will facilitate the&#xD;
      collection of reliable data on patient's injection behavior and adherence, which should be&#xD;
      unaffected by recall bias or reporting bias.&#xD;
&#xD;
      To better understand the utilities of the new BETACONNECT device and characterize its&#xD;
      contribution to adherence, we plan to prospectively follow-up MS patients using this device&#xD;
      for 24 weeks. The study will take place in a real-life setting in Neurology centers across&#xD;
      Europe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2014</start_date>
  <completion_date type="Actual">November 8, 2016</completion_date>
  <primary_completion_date type="Actual">July 19, 2016</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>Adherence to therapy at the final visit.</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with and evaluation of the BETACONNECT auto-injector</measure>
    <time_frame>At baseline,4 weeks,12 weeks and 24 weeks</time_frame>
    <description>Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injection site pain and prophylactic analgesic use</measure>
    <time_frame>At baseline,4 weeks,12 weeks and 24 weeks</time_frame>
    <description>Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>At baseline,12 weeks and 24 weeks</time_frame>
    <description>Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>At baseline,12 weeks and 24 weeks</time_frame>
    <description>Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>At baseline,12 weeks and 24 weeks</time_frame>
    <description>Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>At baseline,12 weeks and 24 weeks</time_frame>
    <description>Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition</measure>
    <time_frame>At baseline,12 weeks and 24 weeks</time_frame>
    <description>Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local skin reactions</measure>
    <time_frame>At baseline,4 weeks,12 weeks and 24 weeks</time_frame>
    <description>Local skin reactions will be recorded by HCP evaluation (local inspection).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injection-related specifics</measure>
    <time_frame>At 4 weeks,12 weeks and 24 weeks</time_frame>
    <description>Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">498</enrollment>
  <condition>Multiple Sclerosis, Relapsing Remitting</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interferon beta-1b (Betaferon®, BAY 86-5046)</intervention_name>
    <description>Patients will be treated with Betaferon</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BETACONNECT</intervention_name>
    <description>Auto-injector device to support the injection of Betaferon</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of patients with relapsing remitting multiple sclerosis&#xD;
        (RRMS) or patients with a clinically isolated syndrome (CIS) who are treated with Betaferon&#xD;
        or will be treated with Betaferon® according to the attending physician's decision and for&#xD;
        whom the patient and the physician have agreed to use the BETACONNECT device.&#xD;
&#xD;
        The study will be conducted in neurological centers and neurology departments specialized&#xD;
        in the treatment of Multiple Sclerosis patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically&#xD;
             isolated syndrome.&#xD;
&#xD;
          -  Patients must be on treatment with Betaferon or the decision to treat a patient with&#xD;
             Betaferon has been made by the attending physician.&#xD;
&#xD;
          -  Patient and attending physicians must have agreed on the usage of the BETACONNECT&#xD;
             auto-injector device.&#xD;
&#xD;
          -  Written informed consent must be obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving any other disease modifying drug.&#xD;
&#xD;
          -  Contraindications of Betaferon described in the Summary of Product Characteristics.&#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>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Many locations</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bosnia and Herzegovina</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>Switzerland</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>November 5, 2017</last_update_submitted>
  <last_update_submitted_qc>November 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 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>
  <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/NCT02247310
org study id: 17591
secondary id: BF1401
nct id: NCT02247310
lead sponsor: 
has dmc: No
Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as
      well as the challenge to achieve high adherence to treatment, evaluating the benefits of any
      new measure to improve adherence is important. The data storage capabilities of the
      BETACONNECT device, including the automated recording of injections, will facilitate the
      collection of reliable data on patient's injection behavior and adherence, which should be
      unaffected by recall bias or reporting bias.

      To better understand the utilities of the new BETACONNECT device and characterize its
      contribution to adherence, we plan to prospectively follow-up MS patients using this device
      for 24 weeks. The study will take place in a real-life setting in Neurology centers across
      Europe.
observational model: Cohort
time perspective: Prospective
measure: Adherence to therapy at the final visit.
time frame: Up to 24 weeks
measure: Satisfaction with and evaluation of the BETACONNECT auto-injector
time frame: At baseline,4 weeks,12 weeks and 24 weeks
description: Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire
measure: Injection site pain and prophylactic analgesic use
time frame: At baseline,4 weeks,12 weeks and 24 weeks
description: Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire
measure: Health related quality of life
time frame: At baseline,12 weeks and 24 weeks
description: Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
measure: Anxiety
time frame: At baseline,12 weeks and 24 weeks
description: Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).
measure: Depression
time frame: At baseline,12 weeks and 24 weeks
description: Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).
measure: Fatigue
time frame: At baseline,12 weeks and 24 weeks
description: Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).
measure: Cognition
time frame: At baseline,12 weeks and 24 weeks
description: Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).
measure: Local skin reactions
time frame: At baseline,4 weeks,12 weeks and 24 weeks
description: Local skin reactions will be recorded by HCP evaluation (local inspection).
measure: Injection-related specifics
time frame: At 4 weeks,12 weeks and 24 weeks
description: Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
arm group label: Cohort 1
description: Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device.
intervention type: Drug
intervention name: Interferon beta-1b (Betaferon®, BAY 86-5046)
description: Patients will be treated with Betaferon
arm group label: Cohort 1
intervention type: Device
intervention name: BETACONNECT
description: Auto-injector device to support the injection of Betaferon
arm group label: Cohort 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: Bosnia and Herzegovina
country: Croatia
country: Czechia
country: France
country: Greece
country: Hungary
country: Italy
country: Spain
country: Switzerland
country: Czech Republic
country: Netherlands
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Interferons
mesh term: Interferon-beta
mesh term: Interferon beta-1b