<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/NCT04458688</url>
  </required_header>
  <id_info>
    <org_study_id>ML41569</org_study_id>
    <nct_id>NCT04458688</nct_id>
  </id_info>
  <brief_title>Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis</brief_title>
  <official_title>Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wayne State University</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 investigators intend to examine the effects of ocrelizumab use in African American&#xD;
      multiple sclerosis disease course compared to Caucasian disease course utilizing imaging&#xD;
      measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography&#xD;
      (OCT-A)..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple sclerosis (MS) is a disease of the central nervous system (CNS). Several lines of&#xD;
      evidence suggest that MS is an autoimmune disease with both T and B-cell activity leading to&#xD;
      CNS inflammation which results in demyelinating injury. Ocrelizumab was FDA approved in March&#xD;
      2017 for relapsing remitting (RRMS) and primary progressive multiple sclerosis (PPMS) by&#xD;
      depleting B cells. It has shown to be effective in reducing the annualized relapse rate,&#xD;
      decreasing disability progression, and reducing the number of new and active MRI brain&#xD;
      lesions.&#xD;
&#xD;
      Previous research studies have reported a more aggressive course in African Americans with&#xD;
      MS, more lesions on the MRI scan, and more severe injury to layers of the eye (specifically&#xD;
      in the retina) compared to Caucasians.&#xD;
&#xD;
      This is a novel study investigating the effect of ocrelizumab in African American relapsing&#xD;
      multiple sclerosis (RMS) patients compared to Caucasian RMS patients using imaging measures,&#xD;
      specifically multimodal magnetic resonance imaging (MRI) and optical coherence&#xD;
      tomography-angiography (OCTA). This is a non-drug intervention study; therefore, patients who&#xD;
      are recruited will have already decided to make ocrelizumab their disease-modifying therapy&#xD;
      before enrollment. The study will recruit 86 (including 6 potential screen fails) patients in&#xD;
      total (40 African American patients and 40 Caucasian patients who are matched by age, sex,&#xD;
      disease duration, and disease disability. The study will consist of 5 visits in six-month&#xD;
      intervals across two years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2021</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Magnetic Resonance Imaging (MRI) with contrast</measure>
    <time_frame>Change in MRI at BL, Month 6, Month 12, and Month 24</time_frame>
    <description>Approximately a 1 hour MRI with contrast (administered via IV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Optical Coherence Tomography Angiography (OCTA)</measure>
    <time_frame>Change in OCTA at BL, Month 12, and Month 24</time_frame>
    <description>Eye scan with contrast (administered via IV)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Multiple Sclerosis, Relapsing-Remitting</condition>
  <arm_group>
    <arm_group_label>African Americans with RRMS</arm_group_label>
    <description>Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as African American.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caucasian American with RRMS</arm_group_label>
    <description>Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as Caucasian American.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation of Ocrelizumab as Treatment in RRMS Patients</intervention_name>
    <description>It is decided by the patient and their physician to begin taking ocrelizumab PRIOR to study enrollment. The study is only observing the effects of ocrelizumab as a pre-decided treatment option for a patient's MS.</description>
    <arm_group_label>African Americans with RRMS</arm_group_label>
    <arm_group_label>Caucasian American with RRMS</arm_group_label>
    <other_name>Observing Ocrelizumab Use</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to&#xD;
        start or recently started using ocrelizumab as their disease modifying therapy. Age range:&#xD;
        18 to 60 years old. Ethnicity: self-described as African American or Caucasian.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who have chosen to start ocrelizumab and for whom ocrelizumab is determined&#xD;
             to be the most appropriate standard-of-care disease modifying therapy (DMT) by the&#xD;
             treating neurologist.&#xD;
&#xD;
          2. May be treatment naive, or had suboptimal response to no more than one DMT after an&#xD;
             adequate course of treatment (defined as treatment duration of 6+ months).&#xD;
&#xD;
          3. Age 18 to 60 years old.&#xD;
&#xD;
          4. Ethnicity: self-identified as African American or Caucasian.&#xD;
&#xD;
          5. Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised&#xD;
             McDonald criteria.&#xD;
&#xD;
          6. EDSS from 0 to 6 (inclusive) at baseline visit.&#xD;
&#xD;
          7. Able to give informed consent.&#xD;
&#xD;
          8. Able to have MRI scans.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment with another monoclonal antibody, including but not limited to natalizumab,&#xD;
             alemtuzumab, daclizumab.&#xD;
&#xD;
          2. Failed 2 or more DMTs.&#xD;
&#xD;
          3. Treatment with immunosuppressant agents, such as chemotherapeutic agents.&#xD;
&#xD;
          4. Claustrophobia.&#xD;
&#xD;
          5. Allergy to contrast.&#xD;
&#xD;
          6. Significant medical problems that the PI determines will interfere with the conduct of&#xD;
             the study.&#xD;
&#xD;
          7. Relapse or use of corticosteroids within 30 days prior to baseline visit.&#xD;
&#xD;
          8. Pregnancy.&#xD;
&#xD;
          9. History of kidney or liver insufficiency.&#xD;
&#xD;
         10. History of malignancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evanthia Bernitsas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zahid Latif</last_name>
    <phone>3139660473</phone>
    <email>zahidlatif@wayne.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kelly Jia</last_name>
    <phone>313-966-9407</phone>
    <email>xjia@med.wayne.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zahid Latif</last_name>
      <phone>313-966-0473</phone>
      <email>zahidlatif@wayne.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kelly Jia</last_name>
      <phone>313-966-9407</phone>
      <email>xjia@med.wayne.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 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>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Evanthia Bernitsas, MD</investigator_full_name>
    <investigator_title>Prinipal Investigator</investigator_title>
  </responsible_party>
  <keyword>multiple sclerosis</keyword>
  <keyword>ocrelizumab</keyword>
  <keyword>magnetic resonance imaging (MRI)</keyword>
  <keyword>optical coherence tomography angiography (OCTA)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</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>Yes</sharing_ipd>
    <ipd_description>Study protocol, ICFs, study reports, statistical analysis plans, secure CRFs, and results will be shared with Roche/Genentech Inc. All patient data will have a unique number/digit code when sent to protect patient identity.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available for the duration of the study and up to 15 years after the last patient has completed the study.</ipd_time_frame>
    <ipd_access_criteria>All data will be stored and shared in electronic case report form (eCRF) format.</ipd_access_criteria>
  </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/NCT04458688
org study id: ML41569
nct id: NCT04458688
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The investigators intend to examine the effects of ocrelizumab use in African American
      multiple sclerosis disease course compared to Caucasian disease course utilizing imaging
      measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography
      (OCT-A)..
Multiple sclerosis (MS) is a disease of the central nervous system (CNS). Several lines of
      evidence suggest that MS is an autoimmune disease with both T and B-cell activity leading to
      CNS inflammation which results in demyelinating injury. Ocrelizumab was FDA approved in March
      2017 for relapsing remitting (RRMS) and primary progressive multiple sclerosis (PPMS) by
      depleting B cells. It has shown to be effective in reducing the annualized relapse rate,
      decreasing disability progression, and reducing the number of new and active MRI brain
      lesions.

      Previous research studies have reported a more aggressive course in African Americans with
      MS, more lesions on the MRI scan, and more severe injury to layers of the eye (specifically
      in the retina) compared to Caucasians.

      This is a novel study investigating the effect of ocrelizumab in African American relapsing
      multiple sclerosis (RMS) patients compared to Caucasian RMS patients using imaging measures,
      specifically multimodal magnetic resonance imaging (MRI) and optical coherence
      tomography-angiography (OCTA). This is a non-drug intervention study; therefore, patients who
      are recruited will have already decided to make ocrelizumab their disease-modifying therapy
      before enrollment. The study will recruit 86 (including 6 potential screen fails) patients in
      total (40 African American patients and 40 Caucasian patients who are matched by age, sex,
      disease duration, and disease disability. The study will consist of 5 visits in six-month
      intervals across two years.
observational model: Case-Control
time perspective: Prospective
measure: Magnetic Resonance Imaging (MRI) with contrast
time frame: Change in MRI at BL, Month 6, Month 12, and Month 24
description: Approximately a 1 hour MRI with contrast (administered via IV)
measure: Optical Coherence Tomography Angiography (OCTA)
time frame: Change in OCTA at BL, Month 12, and Month 24
description: Eye scan with contrast (administered via IV)
arm group label: African Americans with RRMS
description: Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as African American.
arm group label: Caucasian American with RRMS
description: Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as Caucasian American.
intervention type: Other
intervention name: Observation of Ocrelizumab as Treatment in RRMS Patients
description: It is decided by the patient and their physician to begin taking ocrelizumab PRIOR to study enrollment. The study is only observing the effects of ocrelizumab as a pre-decided treatment option for a patient's MS.
arm group label: African Americans with RRMS
arm group label: Caucasian American with RRMS
other name: Observing Ocrelizumab Use
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Evanthia Bernitsas, MD
role: Principal Investigator
affiliation: Wayne State University
last name: Zahid Latif
phone: 3139660473
email: zahidlatif@wayne.edu
last name: Kelly Jia
phone: 313-966-9407
email: xjia@med.wayne.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Evanthia Bernitsas, MD
investigator title: Prinipal Investigator
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Ocrelizumab
sharing ipd: Yes
ipd description: Study protocol, ICFs, study reports, statistical analysis plans, secure CRFs, and results will be shared with Roche/Genentech Inc. All patient data will have a unique number/digit code when sent to protect patient identity.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available for the duration of the study and up to 15 years after the last patient has completed the study.
ipd access criteria: All data will be stored and shared in electronic case report form (eCRF) format.