<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/NCT02230969</url>
  </required_header>
  <id_info>
    <org_study_id>105MS401</org_study_id>
    <nct_id>NCT02230969</nct_id>
  </id_info>
  <brief_title>Plegridy Observational Program</brief_title>
  <acronym>POP</acronym>
  <official_title>Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biogen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of the study are to determine the incidence of serious adverse events&#xD;
      (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical&#xD;
      practice and to assess the overall long-term clinical effectiveness of Plegridy in&#xD;
      participants with relapsing forms of MS in routine clinical practice. The secondary&#xD;
      objectives of this study in this study population are to describe Plegridy prescription and&#xD;
      utilization adherence patterns in routine clinical practice; to assess the specific long-term&#xD;
      clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine&#xD;
      clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical&#xD;
      practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS),&#xD;
      injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to&#xD;
      treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness&#xD;
      of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS);&#xD;
      to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare&#xD;
      resource consumption, and treatment adherence over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2014</start_date>
  <completion_date type="Actual">January 20, 2022</completion_date>
  <primary_completion_date type="Actual">January 20, 2022</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>Safety as measured by the incidence proportion of SAEs</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as measured by the incidence rate of SAEs</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical NEDA as measured by the proportion of participants with no disability progression</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prescription and utilization patterns as measured by prescribed dosing frequency</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescription and utilization patterns as measured by duration of Plegridy use</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse activity as measured by annualized relapse rate (ARR)</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse activity as measured by time to first relapse</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse activity as measured by the proportion of participants with relapse</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse activity as measured by the distribution of the number of relapses</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability progression as measured by the proportion of participants with sustained progression for at least six months</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Disability progression measured by the Expanded Disability Status Scale (EDSS). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who meet one of the following criteria: an increase of ≥ 1 point from baseline system score of ≥ 1 or an increase of ≥ 2 points from baseline system score of 0 in at least 2 physical functional systems, or an increase of ≥ 2 points from baseline system score of ≥ 1 or an increase of ≥ 3 points from baseline system score of 0 in any 1 physical functional system. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability progression as measured by the time to sustained disability progression for at least six months</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence proportion of non-serious AEs leading to treatment discontinuation</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of non-serious AEs leading to treatment discontinuation</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in FLS assessment and FLS-VAS over time</measure>
    <time_frame>Baseline to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time</measure>
    <time_frame>Baseline to 5 years</time_frame>
    <description>The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires</measure>
    <time_frame>Baseline to 5 years</time_frame>
    <description>Where pen/syringe collection is locally allowed, treatment adherence will also be assessed by the proportion of used auto-injector pens/pre-filled syringes out of the total number of pens/syringes prescribed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of MS-related and non-MS-related physician visits, specialists' visits, use of physiotherapy, hospitalizations and lengths of stay, and emergency room/department visits</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1208</enrollment>
  <condition>Relapsing Forms of Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>peginterferon beta-1a</arm_group_label>
    <description>Plegridy will not be supplied for this study. The study will collect data in an observational manner from participants who are prescribed Plegridy by physicians, according to the approved label in the respective country.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>peginterferon beta-1a</intervention_name>
    <description>Administered as specified in the treatment arm</description>
    <arm_group_label>peginterferon beta-1a</arm_group_label>
    <other_name>BIIB017</other_name>
    <other_name>PEG IFN β-1a</other_name>
    <other_name>Plegridy</other_name>
    <other_name>PEGylated Interferon Beta-1a</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will be conducted in participants with relapsing forms of MS who are newly or&#xD;
        currently prescribed Plegridy as prescribed under routine clinical practice and&#xD;
        participants who participated in Study 105MS302 (NCT01332019) or Study 105MS303&#xD;
        (NCT01939002).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Patient with MS who is newly, or is currently, prescribed Plegridy according to local&#xD;
             label including patients who participated in Study 105MS302 (NCT01332019) or Study&#xD;
             105MS303 (NCT01939002).&#xD;
&#xD;
          -  Patient willing and able to complete patient-reported outcomes (PRO) with minimal&#xD;
             assistance.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent enrollment in any clinical trial of an investigational product.&#xD;
             Participation in non-interventional study can be allowed as long as this participation&#xD;
             does not interfere with this protocol or is likely to affect the subject's ability to&#xD;
             comply with the protocol.&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Biogen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Homewood</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>California City</city>
        <state>California</state>
        <zip>93449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hanford</city>
        <state>California</state>
        <zip>93230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Basalt</city>
        <state>Colorado</state>
        <zip>81621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30327</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Schaumburg</city>
        <state>Illinois</state>
        <zip>60173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lexington</city>
        <state>Massachusetts</state>
        <zip>02421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48034</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Royal</city>
        <state>South Carolina</state>
        <zip>29935</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37934</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Lambton Heights</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Irvine</city>
        <state>Ayrshire</state>
        <zip>KA128SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR13LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salford</city>
        <state>Greater Manchester</state>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Inverness</city>
        <state>Highland Region</state>
        <zip>IV2 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE5 4 PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glasgow</city>
        <state>Strathclyde</state>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Swansea</city>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>peginterferon</keyword>
  <keyword>relapsing</keyword>
  <keyword>pegylated</keyword>
  <keyword>Subcutaneous</keyword>
  <keyword>Injectable</keyword>
  <keyword>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>
  <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-1a</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/</ipd_description>
    <ipd_url>https://vivli.org/</ipd_url>
  </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/NCT02230969
org study id: 105MS401
nct id: NCT02230969
lead sponsor: 
has dmc: No
The primary objectives of the study are to determine the incidence of serious adverse events
      (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical
      practice and to assess the overall long-term clinical effectiveness of Plegridy in
      participants with relapsing forms of MS in routine clinical practice. The secondary
      objectives of this study in this study population are to describe Plegridy prescription and
      utilization adherence patterns in routine clinical practice; to assess the specific long-term
      clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine
      clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical
      practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS),
      injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to
      treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness
      of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS);
      to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare
      resource consumption, and treatment adherence over time.
observational model: Cohort
time perspective: Prospective
measure: Safety as measured by the incidence proportion of SAEs
time frame: Up to 5 years
measure: Safety as measured by the incidence rate of SAEs
time frame: Up to 5 years
measure: Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
time frame: Up to 5 years
measure: Clinical NEDA as measured by the proportion of participants with no disability progression
time frame: Up to 5 years
measure: Prescription and utilization patterns as measured by prescribed dosing frequency
time frame: Up to 5 years
measure: Prescription and utilization patterns as measured by duration of Plegridy use
time frame: Up to 5 years
measure: Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy
time frame: Up to 5 years
measure: Relapse activity as measured by annualized relapse rate (ARR)
time frame: Up to 5 years
measure: Relapse activity as measured by time to first relapse
time frame: Up to 5 years
measure: Relapse activity as measured by the proportion of participants with relapse
time frame: Up to 5 years
measure: Relapse activity as measured by the distribution of the number of relapses
time frame: Up to 5 years
measure: Disability progression as measured by the proportion of participants with sustained progression for at least six months
time frame: Up to 5 years
description: Disability progression measured by the Expanded Disability Status Scale (EDSS). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who meet one of the following criteria: an increase of ≥ 1 point from baseline system score of ≥ 1 or an increase of ≥ 2 points from baseline system score of 0 in at least 2 physical functional systems, or an increase of ≥ 2 points from baseline system score of ≥ 1 or an increase of ≥ 3 points from baseline system score of 0 in any 1 physical functional system. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later.
measure: Disability progression as measured by the time to sustained disability progression for at least six months
time frame: Up to 5 years
measure: Incidence proportion of non-serious AEs leading to treatment discontinuation
time frame: Up to 5 years
measure: Incidence rate of non-serious AEs leading to treatment discontinuation
time frame: Up to 5 years
measure: Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS
time frame: Up to 5 years
measure: Changes in FLS assessment and FLS-VAS over time
time frame: Baseline to 5 years
measure: Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time
time frame: Baseline to 5 years
description: The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
measure: Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires
time frame: Baseline to 5 years
description: Where pen/syringe collection is locally allowed, treatment adherence will also be assessed by the proportion of used auto-injector pens/pre-filled syringes out of the total number of pens/syringes prescribed.
measure: Frequency of MS-related and non-MS-related physician visits, specialists' visits, use of physiotherapy, hospitalizations and lengths of stay, and emergency room/department visits
time frame: Up to 5 years
arm group label: peginterferon beta-1a
description: Plegridy will not be supplied for this study. The study will collect data in an observational manner from participants who are prescribed Plegridy by physicians, according to the approved label in the respective country.
intervention type: Drug
intervention name: peginterferon beta-1a
description: Administered as specified in the treatment arm
arm group label: peginterferon beta-1a
other name: BIIB017
other name: PEG IFN β-1a
other name: Plegridy
other name: PEGylated Interferon Beta-1a
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Biogen
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country: Australia
country: Austria
country: Canada
country: Denmark
country: France
country: Germany
country: Ireland
country: Italy
country: Netherlands
country: Portugal
country: Spain
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Interferons
mesh term: Interferon-beta
mesh term: Interferon beta-1a
sharing ipd: Yes
ipd description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
ipd url: https://vivli.org/