<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/NCT02980640</url>
  </required_header>
  <id_info>
    <org_study_id>PB_2016-00894</org_study_id>
    <nct_id>NCT02980640</nct_id>
  </id_info>
  <brief_title>Swiss Multiple Sclerosis Registry</brief_title>
  <acronym>SMSR</acronym>
  <official_title>Swiss Multiple Sclerosis Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Multiple Sclerosis Registry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zurich, Epidemiology, Biostatistics and Prevention Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Schweizerische Multiple Sklerose Gesellschaft</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Multiple Sclerosis Registry</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Swiss Multiple Sclerosis Registry is a national, patient-centered registry with the aim&#xD;
      to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of&#xD;
      persons living with MS in Switzerland.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Swiss Multiple Sclerosis Registry is a national, patient-centered research project with&#xD;
      the aim to document the epidemiology of multiple sclerosis (MS), as well as the quality of&#xD;
      life of persons living with MS in Switzerland. The Swiss MS Registry pursues a &quot;Citizen&#xD;
      Science&quot; approach, that is, persons with MS are not just study participants but also act as&#xD;
      MS experts and are active contributors to the interdisciplinary Swiss MS Registry research&#xD;
      network. Initiated and funded by the Swiss MS Society, the Swiss MS Registry represents a&#xD;
      collaborative effort by numerous MS caregivers, researchers and persons with MS. It is hosted&#xD;
      by the Epidemiology, Biostatistics and Prevention Institute at the University of Zurich.&#xD;
&#xD;
      How many MS-affected persons are living in Switzerland and how are they coping with MS in&#xD;
      their daily lives? What is the current situation with regard to access to and use of drug and&#xD;
      non-drug treatments for MS? These and other questions are addressed by means of semi-annual&#xD;
      surveys. Further research activities concern the quality of life of persons with MS,&#xD;
      mobility, personal resources and support by friends and family, work situation, mental&#xD;
      health, clinical progression of MS, as well as alternative therapies.&#xD;
&#xD;
      Owing to a flexible study design, participants can decide between different levels of&#xD;
      commitment (from one-time surveys to repeated, semiannual surveys and medical records&#xD;
      review). Furthermore, study participants receive summaries of their data as charts and&#xD;
      tables. Data collection primarily occurs via a newly designed online platform, but&#xD;
      paper-and-pencil questionnaires are also available. As an additional incentive, the online&#xD;
      platform includes a diary with basic capabilities for analyses and printing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">June 2041</completion_date>
  <primary_completion_date type="Anticipated">June 2041</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>25 Years</target_duration>
  <primary_outcome>
    <measure>Change in Health-Related Quality of Life</measure>
    <time_frame>Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months</time_frame>
    <description>Assessment via EQ-5D</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Self-Assessment of Health Status</measure>
    <time_frame>Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months</time_frame>
    <description>Assessment via Visual Analogue Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of MS Symptoms</measure>
    <time_frame>Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months</time_frame>
    <description>Self-report of new and recurrent MS symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Drug Effects</measure>
    <time_frame>Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months</time_frame>
    <description>Self-report of unwanted drug side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of MS Relapse</measure>
    <time_frame>Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months</time_frame>
    <description>Self-report of MS relapse(s)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Multiple Sclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All persons with Multiple Sclerosis who either live in Switzerland or who recieve MS care&#xD;
        in Switzerland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons with a confirmed Multiple Sclerosis Diagnosis&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Living in Switzerland or receiving MS care in Switzerland&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years&#xD;
&#xD;
          -  Not living in Switzerland and not receiving MS care in Switzerland&#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>Milo Puhan, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Milo Puhan, MD PhD</last_name>
    <phone>++41 (0)44 634 4610</phone>
    <email>miloalan.puhan@uzh.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Viktor von Wyl, PhD</last_name>
    <phone>++41 (0)44 634 6380</phone>
    <email>viktor.vonwyl@uzh.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Zurich; Epidemiology, Biostatistics &amp; Prevention Institute</name>
      <address>
        <city>Zurich</city>
        <zip>8001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Viktor von Wyl, PhD</last_name>
      <phone>++41 (0)44 634 6380</phone>
      <email>viktor.vonwyl@uzh.ch</email>
    </contact>
    <contact_backup>
      <last_name>Milo Puhan, MD PhD</last_name>
      <phone>++41 (0)44 634 4610</phone>
      <email>miloalan.puhan@uzh.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.ms-register.ch</url>
    <description>Description of Swiss MS Registry in German</description>
  </link>
  <link>
    <url>http://www.registre-sep.ch</url>
    <description>Description of Swiss MS Registry in French</description>
  </link>
  <link>
    <url>http://www.registro-sm.ch</url>
    <description>Description of Swiss MS Registry in Italian</description>
  </link>
  <link>
    <url>https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-018-1118-0</url>
    <description>Protocol Description of the Swiss Multiple Sclerosis Registry</description>
  </link>
  <link>
    <url>https://smw.ch/article/doi/smw.2018.14623</url>
    <description>Description of main study design of the Swiss Multiple Sclerosis Registry</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Treatment</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Symptoms</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pseudonimized data are shared with other researchers upon approval of a project proposal. Guidelines describing submission and approval process are in place.</ipd_description>
  </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/NCT02980640
org study id: PB_2016-00894
nct id: NCT02980640
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The Swiss Multiple Sclerosis Registry is a national, patient-centered registry with the aim
      to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of
      persons living with MS in Switzerland.
The Swiss Multiple Sclerosis Registry is a national, patient-centered research project with
      the aim to document the epidemiology of multiple sclerosis (MS), as well as the quality of
      life of persons living with MS in Switzerland. The Swiss MS Registry pursues a "Citizen
      Science" approach, that is, persons with MS are not just study participants but also act as
      MS experts and are active contributors to the interdisciplinary Swiss MS Registry research
      network. Initiated and funded by the Swiss MS Society, the Swiss MS Registry represents a
      collaborative effort by numerous MS caregivers, researchers and persons with MS. It is hosted
      by the Epidemiology, Biostatistics and Prevention Institute at the University of Zurich.

      How many MS-affected persons are living in Switzerland and how are they coping with MS in
      their daily lives? What is the current situation with regard to access to and use of drug and
      non-drug treatments for MS? These and other questions are addressed by means of semi-annual
      surveys. Further research activities concern the quality of life of persons with MS,
      mobility, personal resources and support by friends and family, work situation, mental
      health, clinical progression of MS, as well as alternative therapies.

      Owing to a flexible study design, participants can decide between different levels of
      commitment (from one-time surveys to repeated, semiannual surveys and medical records
      review). Furthermore, study participants receive summaries of their data as charts and
      tables. Data collection primarily occurs via a newly designed online platform, but
      paper-and-pencil questionnaires are also available. As an additional incentive, the online
      platform includes a diary with basic capabilities for analyses and printing.
observational model: Cohort
time perspective: Prospective
measure: Change in Health-Related Quality of Life
time frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
description: Assessment via EQ-5D
measure: Change in Self-Assessment of Health Status
time frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
description: Assessment via Visual Analogue Scale
measure: Occurrence of MS Symptoms
time frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
description: Self-report of new and recurrent MS symptoms
measure: Occurrence of Adverse Drug Effects
time frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
description: Self-report of unwanted drug side effects
measure: Occurrence of MS Relapse
time frame: Baseline; 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
description: Self-report of MS relapse(s)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Milo Puhan, MD PhD
role: Principal Investigator
affiliation: University of Zurich
last name: Milo Puhan, MD PhD
phone: ++41 (0)44 634 4610
email: miloalan.puhan@uzh.ch
last name: Viktor von Wyl, PhD
phone: ++41 (0)44 634 6380
email: viktor.vonwyl@uzh.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
url: http://www.ms-register.ch
description: Description of Swiss MS Registry in German
url: http://www.registre-sep.ch
description: Description of Swiss MS Registry in French
url: http://www.registro-sm.ch
description: Description of Swiss MS Registry in Italian
url: https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-018-1118-0
description: Protocol Description of the Swiss Multiple Sclerosis Registry
url: https://smw.ch/article/doi/smw.2018.14623
description: Description of main study design of the Swiss Multiple Sclerosis Registry
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Yes
ipd description: Pseudonimized data are shared with other researchers upon approval of a project proposal. Guidelines describing submission and approval process are in place.