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/NCT05974852</url>
    </required_header>
    <id_info>
      <org_study_id>00007537</org_study_id>
      <nct_id>NCT05974852</nct_id>
    </id_info>
    <brief_title>Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS</brief_title>
    <acronym>ORATORIO-CP</acronym>
    <official_title>Effect of Ocrelizumab on Choroid Plexus Changes 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this non-interventional, observational study is to learn if cortical plexus&#xD;
        enhancement in patients with primary progressive multiple sclerosis occurs in response to the&#xD;
        autoimmune inflammatory process.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To study the effect of ocrelizumab on choroid plexus changes 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>T2 lesion volume</measure>
      <time_frame>5 years</time_frame>
      <description>T2 lesion volume as measured using MRI.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in choroid plexus</measure>
      <time_frame>5 years</time_frame>
      <description>Changes in choroid plexus as measured using MRI.</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 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>
    </eligibility>
    <overall_contact>
      <last_name>Robert Zivadinov, MD</last_name>
      <phone>833-914-4967</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>
    <location>
      <facility>
        <name>Buffalo Neuroimaging Analysis Center</name>
        <address>
          <city>Buffalo</city>
          <state>New York</state>
          <zip>14203</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 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/NCT05974852
  org study id: 00007537
  nct id: NCT05974852
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this non-interventional, observational study is to learn if cortical plexus
        enhancement in patients with primary progressive multiple sclerosis occurs in response to the
        autoimmune inflammatory process.
  To study the effect of ocrelizumab on choroid plexus changes 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: T2 lesion volume
  time frame: 5 years
  description: T2 lesion volume as measured using MRI.
  measure: Changes in choroid plexus
  time frame: 5 years
  description: Changes in choroid plexus as measured using MRI.
  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
  last name: Robert Zivadinov, MD
  phone: 833-914-4967
  email: rzivadinov@bnac.net
  last name: Cheryl L Kennedy, MPH
  phone: 716-864-8101
  email: ckennedy@bnac.net
  facility: 
  country: United States
  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