xml: <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/NCT05974839</url>
    </required_header>
    <id_info>
      <org_study_id>00007536</org_study_id>
      <nct_id>NCT05974839</nct_id>
    </id_info>
    <brief_title>Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)</brief_title>
    <acronym>ORATORIO-Cort</acronym>
    <official_title>Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With Primary-progressive Multiple Sclerosis Participating in the ORATORIO: a Post-hoc Analysis of a Double-blind, Randomized, Phase 3, Placebo-controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>State University of New York at Buffalo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Genentech, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>State University of New York at Buffalo</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 goal of this non-interventional, observational study is to determine whether cortical&#xD;
        pathology can be slowed down by use of ocrelizumab.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To study the effect of ocrelizumab on cortical lesion accumulation in patients with&#xD;
        primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of&#xD;
        a double-blind, randomized, phase 3, placebo-controlled study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cortical lesion number accumulation</measure>
      <time_frame>5 years</time_frame>
      <description>Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cortical lesion number accumulation and disability.</measure>
      <time_frame>5 years</time_frame>
      <description>Cortical lesion number accumulation as measured by MRI for subjects who developed disability over the course of the placebo-controlled phase of the study.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">732</enrollment>
    <condition>Primary Progressive Multiple Sclerosis</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ocrelizumab</intervention_name>
      <description>Non-interventional</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Primary Progressive Multiple Sclerosis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient participating in the ORATORIO study&#xD;
  &#xD;
            -  MRI scans available at baseline&#xD;
  &#xD;
            -  Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 2D/3D T1-WI at baseline&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Robert Zivadinov, MD</last_name>
      <phone>733-914-4967</phone>
      <email>rzivadinov@bnac.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cheryl L Kennedy, MPH</last_name>
      <phone>716-864-8101</phone>
      <email>ckennedy@bnac.net</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
      <investigator_full_name>Robert Zivadinov, MD, PhD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Multiple Sclerosis, Chronic Progressive</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ocrelizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974839
  org study id: 00007536
  nct id: NCT05974839
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this non-interventional, observational study is to determine whether cortical
        pathology can be slowed down by use of ocrelizumab.
  To study the effect of ocrelizumab on cortical lesion accumulation in patients with
        primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of
        a double-blind, randomized, phase 3, placebo-controlled study.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Cortical lesion number accumulation
  time frame: 5 years
  description: Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.
  measure: Cortical lesion number accumulation and disability.
  time frame: 5 years
  description: Cortical lesion number accumulation as measured by MRI for subjects who developed disability over the course of the placebo-controlled phase of the study.
  intervention type: Other
  intervention name: Ocrelizumab
  description: Non-interventional
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Robert Zivadinov, MD
  phone: 733-914-4967
  email: rzivadinov@bnac.net
  last name: Cheryl L Kennedy, MPH
  phone: 716-864-8101
  email: ckennedy@bnac.net
  responsible party type: Principal Investigator
  investigator affiliation: State University of New York at Buffalo
  investigator full name: Robert Zivadinov, MD, PhD
  investigator title: Principal Investigator
  mesh term: Multiple Sclerosis
  mesh term: Multiple Sclerosis, Chronic Progressive
  mesh term: Sclerosis
  mesh term: Ocrelizumab
  sharing ipd: No