<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/NCT03291756</url>
  </required_header>
  <id_info>
    <org_study_id>CorEvitas-MS-700</org_study_id>
    <nct_id>NCT03291756</nct_id>
  </id_info>
  <brief_title>Corevitas Multiple Sclerosis (MS) Registry</brief_title>
  <official_title>CorEvitas Multiple Sclerosis (MS) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CorEvitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CorEvitas</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>
      This prospective, non-interventional research registry is designed to study the comparative&#xD;
      effectiveness and comparative safety of approved treatments for MS in a cohort of patients&#xD;
      cared for by neurologists across North America. Secondary objectives include analyzing the&#xD;
      epidemiology and natural history of the disease, its comorbidities, and current treatment&#xD;
      practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the CorEvitas Multiple Sclerosis (MS) Registry is to create a national&#xD;
      cohort of patients with MS. Data collected will be used to better characterize the natural&#xD;
      history of the disease and to extensively evaluate the effectiveness and safety of&#xD;
      medications approved for the treatment of MS. This will be done through the standardized&#xD;
      collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes&#xD;
      (ClinRO), the prevalence and incidence of comorbidities and adverse events, medication&#xD;
      utilization patterns and patient productivity measures.&#xD;
&#xD;
      The design is a prospective, non-interventional, observational registry for patients with MS&#xD;
      under the care of a licensed neurologist. Longitudinal follow-up data is collected from both&#xD;
      patients and their treating neurologist (also known as &quot;Providers&quot; for a CorEvitas registry&#xD;
      study) every 6 months (+/- 30 days) during routine clinical encounters using CorEvitas&#xD;
      registry forms. These forms collect data on patient demographics, disease duration, medical&#xD;
      history (including all prior and current treatments for MS), smoking status, alcohol use,&#xD;
      disease activity and severity, pain, as well as other clinician- and patient-reported&#xD;
      outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted&#xD;
      safety outcomes. After the enrollment visit, MS patients and physicians will complete the&#xD;
      follow-up questionnaires during regularly scheduled clinical encounters. The goal is to&#xD;
      collect data from patients and providers at six month intervals. Adverse events may be&#xD;
      volunteered spontaneously by the subject, or be discovered as a result of general questioning&#xD;
      by the Investigator. During all CorEvitas related visits with the Investigator, subjects will&#xD;
      be questioned regarding the occurrence of adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Anticipated">December 2100</completion_date>
  <primary_completion_date type="Anticipated">December 2100</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>Number of patients with adverse events (AEs) or serious adverse events (SAEs).</measure>
    <time_frame>Time Frame: A minimum of 10 years from last patient enrolled</time_frame>
    <description>Targeted events include malignancy, anaphylaxis, cardiovascular disease, serious infection, autoimmune disease, MS Relapse, hepatic events, and general serious adverse events.&#xD;
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Patient Clinical Global Impression (PCGI) Scale</measure>
    <time_frame>Time Frame: every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease burden: Relapse Information</measure>
    <time_frame>Time Frame: every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with history of comorbidities</measure>
    <time_frame>Time Frame: at registry enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported: Nine-Hole Peg Test (9-HPT)</measure>
    <time_frame>Time Frame: every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported: Symbol Digit Modalities Test (SMDT)</measure>
    <time_frame>Time Frame: every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)</measure>
    <time_frame>Time Frame: every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: Patient reported :MS Quality of Life, MSIS-29</measure>
    <time_frame>Time Frame: every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported: MS Disability Score29</measure>
    <time_frame>Time Frame: every 6 months for 10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
    <description>Multiple Sclerosis Pts presenting to enrolling sites across the US are invited to enroll if eligible</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are enrolled in the Multiple Sclerosis (MS) Registry during regularly -scheduled&#xD;
        office visits. Selected neurologists are invited to participate as investigators in the&#xD;
        Registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has a diagnosis of MS at the time of enrollment.&#xD;
&#xD;
          2. Age 18 years or older at the time of enrollment.&#xD;
&#xD;
          3. Willing to provide Personal Information.&#xD;
&#xD;
          4. Initiating (prescribed or starting) an Eligible Medication for the treatment of MS at&#xD;
             the enrollment visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Is participating or planning to participate in a double-blind randomized trial for an MS&#xD;
        drug. Note: Concurrent participation in another observational registry or open-label Phase&#xD;
        3b/4 trial is allowed.&#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>Jeffrey Greenberg, MD</last_name>
    <role>Study Director</role>
    <affiliation>CorEvitas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corrona, LLC</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.corevitas.com/</url>
    <description>CorEvitas home page</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</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>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/NCT03291756
org study id: CorEvitas-MS-700
nct id: NCT03291756
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective, non-interventional research registry is designed to study the comparative
      effectiveness and comparative safety of approved treatments for MS in a cohort of patients
      cared for by neurologists across North America. Secondary objectives include analyzing the
      epidemiology and natural history of the disease, its comorbidities, and current treatment
      practices.
The objective of the CorEvitas Multiple Sclerosis (MS) Registry is to create a national
      cohort of patients with MS. Data collected will be used to better characterize the natural
      history of the disease and to extensively evaluate the effectiveness and safety of
      medications approved for the treatment of MS. This will be done through the standardized
      collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes
      (ClinRO), the prevalence and incidence of comorbidities and adverse events, medication
      utilization patterns and patient productivity measures.

      The design is a prospective, non-interventional, observational registry for patients with MS
      under the care of a licensed neurologist. Longitudinal follow-up data is collected from both
      patients and their treating neurologist (also known as "Providers" for a CorEvitas registry
      study) every 6 months (+/- 30 days) during routine clinical encounters using CorEvitas
      registry forms. These forms collect data on patient demographics, disease duration, medical
      history (including all prior and current treatments for MS), smoking status, alcohol use,
      disease activity and severity, pain, as well as other clinician- and patient-reported
      outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted
      safety outcomes. After the enrollment visit, MS patients and physicians will complete the
      follow-up questionnaires during regularly scheduled clinical encounters. The goal is to
      collect data from patients and providers at six month intervals. Adverse events may be
      volunteered spontaneously by the subject, or be discovered as a result of general questioning
      by the Investigator. During all CorEvitas related visits with the Investigator, subjects will
      be questioned regarding the occurrence of adverse events.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with adverse events (AEs) or serious adverse events (SAEs).
time frame: Time Frame: A minimum of 10 years from last patient enrolled
description: Targeted events include malignancy, anaphylaxis, cardiovascular disease, serious infection, autoimmune disease, MS Relapse, hepatic events, and general serious adverse events.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
measure: Patient reported: Patient Clinical Global Impression (PCGI) Scale
time frame: Time Frame: every 6 months for 10 years
measure: Disease burden: Relapse Information
time frame: Time Frame: every 6 months for 10 years
measure: Percentage of patients with history of comorbidities
time frame: Time Frame: at registry enrollment
measure: Physician reported: Nine-Hole Peg Test (9-HPT)
time frame: Time Frame: every 6 months for 10 years
measure: Physician reported: Symbol Digit Modalities Test (SMDT)
time frame: Time Frame: every 6 months for 10 years
measure: Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)
time frame: Time Frame: every 6 months for 10 years
measure: Patient reported: Patient reported :MS Quality of Life, MSIS-29
time frame: Time Frame: every 6 months for 10 years
measure: Patient reported: MS Disability Score29
time frame: Time Frame: every 6 months for 10 years
arm group label: Multiple Sclerosis
description: Multiple Sclerosis Pts presenting to enrolling sites across the US are invited to enroll if eligible
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey Greenberg, MD
role: Study Director
affiliation: CorEvitas
facility: 
country: United States
url: https://www.corevitas.com/
description: CorEvitas home page
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis