Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab

February 2, 2026 updated by: Genentech, Inc.

An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab

Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya, 00100
        • The Aga Khan University-Kenya.
  • Puerto Rico
      • Guaynabo, Puerto Rico, 969
        • Centro Internacional De Mercadeo
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • California
      • Los Angeles, California, United States, 90033-5315
        • Keck School of Medicine of USC
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Jacksonville Beach, Florida, United States, 32250
        • Baptist Neurology - Beaches
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center Inc.
      • Atlanta, Georgia, United States, 30327
        • Atlanta NeuroScience Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60612-3244
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology PC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University Neurology Research Office
      • Baltimore, Maryland, United States, 21201-1642
        • University of Maryland Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School Of Medicine
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Hackensack University Medical Center
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Guilford Neurologic Research Partners, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson University Hospitals, Thomas Jefferson University
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic - Cordova
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Frisco, Texas, United States, 75034
        • North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Multiple Sclerosis Center of Tidewater
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and the Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wheaton Franciscan Healthcare - St. Francis Outpatient Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
  • Participants who self-identify as Black or African American or Hispanic/Latino American
  • Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
  • Neurologically stable for at least 30 days prior to randomization and baseline assessments

Exclusion Criteria:

  • Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)
  • Primary Progressive Multiple Sclerosis (PPMS)
  • Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure
  • Infection Related
  • Cancer Related
  • Pregnant or lactating, or intending to become pregnant during the study
  • Other Medical Conditions
  • Known presence or history of other neurologic disorders
  • Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab
  • Laboratory: abnormalities or findings at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All Participants
Main study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72.
Drug: Ocrelizumab
Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
Time Frame: 48 Weeks
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)
48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48
Time Frame: Week 48
Week 48
Time to protocol-defined event
Time Frame: Week 48
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI
Week 48
Annualized relapse rate at week 48
Time Frame: Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

November 11, 2025

Study Registration Dates

First Submitted

May 1, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML42071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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