<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/NCT04459988</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00066792</org_study_id>
    <nct_id>NCT04459988</nct_id>
  </id_info>
  <brief_title>Mechanistic Study of Ocrevus</brief_title>
  <official_title>Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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 purpose of this study is to investigate the immune cell and other factor changes with&#xD;
      Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for&#xD;
      this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of&#xD;
      Michigan Health System in Ann Arbor. The goal of the study is to understand the role of&#xD;
      regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Change in frequency of regulatory B cells</measure>
    <time_frame>From baseline to 24 months</time_frame>
    <description>Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in frequency of T cell subtypes</measure>
    <time_frame>From baseline to 24 months</time_frame>
    <description>Percentage of T cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Patients with MS</arm_group_label>
    <description>Patients with MS who have been newly prescribed Ocrevus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Healthy Controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ocrelizumab</intervention_name>
    <description>Description Needed</description>
    <arm_group_label>Patients with MS</arm_group_label>
    <other_name>Ocrevus</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be collected after 3, 6, 9, 12, 18 and 24 months of treatment.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will recruit 25 MS patients (Group 1; include 5-10 PPMS and 15-20 RRMS).&#xD;
        Meanwhile, 10 healthy controls (Group 2; HCs) will be recruited to establish baseline&#xD;
        immune cell profiles. The patients and healthy controls will be recruited at the University&#xD;
        of Michigan Neurology Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with MS either with relapsing or primary progressive course; who are newly&#xD;
        starting on ocrelizumab (Ocrevus) at the time of enrollment&#xD;
&#xD;
        OR&#xD;
&#xD;
        Healthy controls who do not have a significant medical conditions such as cancer, chronic&#xD;
        infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are&#xD;
        not on an immune suppressant medication.&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Willing to have blood drawn as scheduled in the protocol&#xD;
&#xD;
          -  Willing and able to complete all procedures and evaluations related to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical or psychiatric conditions that may affect the patient's ability to give&#xD;
             informed consent&#xD;
&#xD;
          -  Has received an experimental drug within 30 days of enrollment&#xD;
&#xD;
          -  Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex,&#xD;
             Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate,&#xD;
             azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus,&#xD;
             etc.)&#xD;
&#xD;
          -  Has any contraindication to high-dose immunotherapy, including pregnancy, trying to&#xD;
             become pregnant, or breast feeding during the study&#xD;
&#xD;
          -  Active hepatitis B virus infection&#xD;
&#xD;
          -  History of life-threatening infusion reaction to Rituxan or Ocrevus&#xD;
&#xD;
          -  Chronic infection or any severe acute infection within 3 months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Mao-Draayer, MD/PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Mao-Draayer, MD/PHD</last_name>
    <phone>734-763-3630</phone>
    <email>maodraay@med.umich.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qi Wu, PHD</last_name>
    <phone>734-764-8971</phone>
    <email>qiw@med.umich.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qi Wu, PhD</last_name>
      <phone>734-764-8971</phone>
      <email>qiw@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Yang Mao-Draayer, MD/PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Yang Mao-Draayer</investigator_full_name>
    <investigator_title>Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>Ocrevus</keyword>
  <keyword>B cell</keyword>
  <keyword>T cell</keyword>
  <keyword>cytokines</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>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>


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/NCT04459988
org study id: HUM00066792
nct id: NCT04459988
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to investigate the immune cell and other factor changes with
      Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for
      this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of
      Michigan Health System in Ann Arbor. The goal of the study is to understand the role of
      regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.
observational model: Cohort
time perspective: Prospective
measure: Change in frequency of regulatory B cells
time frame: From baseline to 24 months
description: Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls
measure: Change in frequency of T cell subtypes
time frame: From baseline to 24 months
description: Percentage of T cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls
arm group label: Patients with MS
description: Patients with MS who have been newly prescribed Ocrevus
arm group label: Healthy Controls
description: Healthy Controls
intervention type: Drug
intervention name: Ocrelizumab
description: Description Needed
arm group label: Patients with MS
other name: Ocrevus
Blood will be collected after 3, 6, 9, 12, 18 and 24 months of treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yang Mao-Draayer, MD/PHD
role: Principal Investigator
affiliation: University of Michigan
last name: Yang Mao-Draayer, MD/PHD
phone: 734-763-3630
email: maodraay@med.umich.edu
last name: Qi Wu, PHD
phone: 734-764-8971
email: qiw@med.umich.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Yang Mao-Draayer
investigator title: Professor of Neurology
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Ocrelizumab
sharing ipd: No