<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/NCT03269175</url>
  </required_header>
  <id_info>
    <org_study_id>19215</org_study_id>
    <secondary_id>2017-001176-31</secondary_id>
    <nct_id>NCT03269175</nct_id>
  </id_info>
  <brief_title>BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies</brief_title>
  <official_title>BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain long-term clinical data from patients approximately 15&#xD;
      years after their first clinical event, who participated in the former BENEFIT 304747 study&#xD;
      and were treated at least once within that study.&#xD;
&#xD;
      This study will collect clinical information on the disease course, on disability, relapses,&#xD;
      cognitive function over time, quality of life, depression, fatigue, resource use, and&#xD;
      employment status. In addition, brain MRI is performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">May 24, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease course since start of BENEFIT as assessed at the time of BENEFIT 15</measure>
    <time_frame>Over 15 years since the subject's first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to first relapse</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to recurrent relapse</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualized relapse rate</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination</measure>
    <time_frame>15 years after the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
    <description>MSFC: Multiple Sclerosis Functional Composite</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to use of ambulatory device</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to dependence on ambulatory device</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to use of wheelchair</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Employment status (Standardized questions)</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
    <description>The current employment will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple sclerosis impact on employment</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Resource use assessment questions: Help from family/regular ambulatory services</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Resource use assessment questions: Additional ambulatory services during relapse</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Resource use assessment questions: Adaptions (past 6 months)</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symbol Digit Modalities Test score (SDMT score)</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
    <description>SDMT: Symbol Digit Modalities Test, Cognitive test&#xD;
For sustained attention, concentration and information processing speed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation of mental processing speed and MRI parameters</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
    <description>EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score</measure>
    <time_frame>Over 15 years since the subject's first clinical event</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Multiple Sclerosis (FAMS score)</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
    <description>FAMS: Functional Assessment of Multiple Sclerosis&#xD;
Questionnaire measuring health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Scale for Motor and Cognitive Functions (FSMC score)</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center of Epidemiological Studies for Depression (CES-D) score</measure>
    <time_frame>At one single visit, 15 years after the subject's first clinical event</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to second line therapy</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first disease-modifying therapies (DMT) other than IFNB-1b</measure>
    <time_frame>Over 15 years since the subject´s first clinical event</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">261</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Experimental arm 15 years ago</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm, offered treatment at MS diagnosis or at Month 24</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brain MRI</intervention_name>
    <description>Brain MRI will be performed</description>
    <arm_group_label>Experimental arm 15 years ago</arm_group_label>
    <arm_group_label>Placebo arm, offered treatment at MS diagnosis or at Month 24</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood samples will be taken</description>
    <arm_group_label>Experimental arm 15 years ago</arm_group_label>
    <arm_group_label>Placebo arm, offered treatment at MS diagnosis or at Month 24</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects who were treated at least once in BENEFIT study 304747 are eligible for&#xD;
             inclusion in the BENEFIT 15 study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who, according to the investigator's judgment, have medical, psychiatric, or&#xD;
             other conditions that compromise the subject's ability to understand the purpose of&#xD;
             the study&#xD;
&#xD;
          -  Suspected clinical instability or unpredictability of the clinical course during the&#xD;
             study(e.g., due to previous surgery or acute stroke)&#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>Medizinische Universität Graz</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus - Universitätskliniken Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CU Saint-Luc/UZ St-Luc</name>
      <address>
        <city>Bruxelles - Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Liège</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital-General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM - Hopital Hotel-Dieu</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Neurological Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava-Poruba</city>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze</name>
      <address>
        <city>Praha 2</city>
        <zip>121 11</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amtssygehuset Glostrup</name>
      <address>
        <city>Glostrup</city>
        <zip>DK-2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopistollinen sairaala, keskussairaala</name>
      <address>
        <city>Tampere</city>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terveystalo Turku</name>
      <address>
        <city>Turku</city>
        <zip>20100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pellegrin - Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital general</name>
      <address>
        <city>Dijon</city>
        <zip>21033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Roger Salengro</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pasteur - Nice</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pontchaillou</name>
      <address>
        <city>Rennes Cedex</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München Grosshadern</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bezirksklinikum</name>
      <address>
        <city>Regensburg</city>
        <state>Bayern</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Hennigsdorf</name>
      <address>
        <city>Hennigsdorf</city>
        <state>Brandenburg</state>
        <zip>16761</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Gießen und Marburg GmbH</name>
      <address>
        <city>Marburg</city>
        <state>Hessen</state>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Klinikum Offenbach GmbH</name>
      <address>
        <city>Offenbach</city>
        <state>Hessen</state>
        <zip>63069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Georg-August-Universität Göttingen</name>
      <address>
        <city>Goettingen</city>
        <state>Niedersachsen</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heinrich-Heine-Universität Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH</name>
      <address>
        <city>Halle</city>
        <state>Sachsen-Anhalt</state>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Erfurt GmbH</name>
      <address>
        <city>Erfurt</city>
        <state>Thüringen</state>
        <zip>99089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Charite zu Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterfy Sandor utcai Korhaz - Rendelointezet</name>
      <address>
        <city>Budapest</city>
        <zip>1076</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uzsoki Utcai Korhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1145</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4012</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent-Gyorgyi Albert Orvostudomanyi Egyetem</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Hebrew University Hospital Ein Kerem</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ist Neurologico Nazionale C.Mondino</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Valle Olona</name>
      <address>
        <city>Varese</city>
        <state>Lombardia</state>
        <zip>21013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. San Luigi Gonzaga</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <state>Toscana</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helse Bergen HF Haukeland universitetssjukehus</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-681</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki w Krakowie</name>
      <address>
        <city>Krakow</city>
        <zip>30-503</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital im. N. Barlickiego</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny nr 4</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia Francisco Gentil - Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Macarena</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucía</state>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciutat Sanitària i Universitària de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciutat Sanitària i Universitaria de la Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional de Málaga</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Universitetssjukhuset</name>
      <address>
        <city>Göteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel-Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Universitätsspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal Infirmary</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products.</description>
  </link>
  <link>
    <url>http://www.clinicaltrialsregister.eu/</url>
    <description>Click here to find information about studies related to Bayer Healthcare products conducted in Europe.</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis</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>
  <!-- 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/NCT03269175
org study id: 19215
secondary id: 2017-001176-31
nct id: NCT03269175
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to obtain long-term clinical data from patients approximately 15
      years after their first clinical event, who participated in the former BENEFIT 304747 study
      and were treated at least once within that study.

      This study will collect clinical information on the disease course, on disability, relapses,
      cognitive function over time, quality of life, depression, fatigue, resource use, and
      employment status. In addition, brain MRI is performed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
time frame: Over 15 years since the subject´s first clinical event
measure: Disease course since start of BENEFIT as assessed at the time of BENEFIT 15
time frame: Over 15 years since the subject's first clinical event
measure: Time to first relapse
time frame: Over 15 years since the subject´s first clinical event
measure: Time to recurrent relapse
time frame: Over 15 years since the subject´s first clinical event
measure: Annualized relapse rate
time frame: Over 15 years since the subject´s first clinical event
measure: Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)
time frame: Over 15 years since the subject´s first clinical event
measure: Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)
time frame: Over 15 years since the subject´s first clinical event
measure: Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination
time frame: 15 years after the subject´s first clinical event
measure: Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)
time frame: Over 15 years since the subject´s first clinical event
measure: Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)
time frame: Over 15 years since the subject´s first clinical event
measure: Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)
time frame: Over 15 years since the subject´s first clinical event
description: MSFC: Multiple Sclerosis Functional Composite
measure: Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
time frame: Over 15 years since the subject´s first clinical event
measure: Time to use of ambulatory device
time frame: Over 15 years since the subject´s first clinical event
measure: Time to dependence on ambulatory device
time frame: Over 15 years since the subject´s first clinical event
measure: Time to use of wheelchair
time frame: Over 15 years since the subject´s first clinical event
measure: Employment status (Standardized questions)
time frame: At one single visit, 15 years after the subject's first clinical event
description: The current employment will be recorded
measure: Multiple sclerosis impact on employment
time frame: At one single visit, 15 years after the subject's first clinical event
measure: Resource use assessment questions: Help from family/regular ambulatory services
time frame: At one single visit, 15 years after the subject's first clinical event
measure: Resource use assessment questions: Additional ambulatory services during relapse
time frame: At one single visit, 15 years after the subject's first clinical event
measure: Resource use assessment questions: Adaptions (past 6 months)
time frame: At one single visit, 15 years after the subject's first clinical event
measure: Symbol Digit Modalities Test score (SDMT score)
time frame: At one single visit, 15 years after the subject's first clinical event
description: SDMT: Symbol Digit Modalities Test, Cognitive test
For sustained attention, concentration and information processing speed
measure: Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)
time frame: At one single visit, 15 years after the subject's first clinical event
measure: Relation of mental processing speed and MRI parameters
time frame: At one single visit, 15 years after the subject's first clinical event
measure: European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score
time frame: Over 15 years since the subject´s first clinical event
description: EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life
measure: European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
time frame: Over 15 years since the subject's first clinical event
measure: Functional Assessment of Multiple Sclerosis (FAMS score)
time frame: Over 15 years since the subject´s first clinical event
description: FAMS: Functional Assessment of Multiple Sclerosis
Questionnaire measuring health-related quality of life
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC score)
time frame: At one single visit, 15 years after the subject's first clinical event
measure: Center of Epidemiological Studies for Depression (CES-D) score
time frame: At one single visit, 15 years after the subject's first clinical event
measure: Time to second line therapy
time frame: Over 15 years since the subject´s first clinical event
measure: Time to first disease-modifying therapies (DMT) other than IFNB-1b
time frame: Over 15 years since the subject´s first clinical event
arm group label: Experimental arm 15 years ago
arm group type: Other
description: This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
arm group label: Placebo arm, offered treatment at MS diagnosis or at Month 24
arm group type: Other
description: This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
intervention type: Other
intervention name: Brain MRI
description: Brain MRI will be performed
arm group label: Experimental arm 15 years ago
arm group label: Placebo arm, offered treatment at MS diagnosis or at Month 24
intervention type: Other
intervention name: Blood sampling
description: Blood samples will be taken
arm group label: Experimental arm 15 years ago
arm group label: Placebo arm, offered treatment at MS diagnosis or at Month 24
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: Canada
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Norway
country: Poland
country: Portugal
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
url: https://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products.
url: http://www.clinicaltrialsregister.eu/
description: Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis