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

NCT04377555 | Completed Phase 4 FDA Drug

• 1 other identifier: ML42071
• Study Type: interventional
• Target: 179
• Locations: 3 countries
• Sites: 28

Brief Summary

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.

Conditions

Multiple Sclerosis, Relapsing

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment

  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 Outcomes (3)

• Time to onset of 24 weeks confirmed disability progression (CDP) at week 48

  Week 48

• Time to protocol-defined event

  Week 48

• Annualized relapse rate at week 48

  Week 48

Study Arms (1)

All Participants

EXPERIMENTAL

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

Interventions

Ocrelizumab DRUG

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.

All Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (28)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033-5315, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Baptist Neurology - Beaches

Jacksonville Beach, Florida, 32250, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Shepherd Center Inc.

Atlanta, Georgia, 30309, United States

Location

Atlanta Neuroscience Institute

Atlanta, Georgia, 30327, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3244, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, 46256, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201-1642, United States

Location

Johns Hopkins University Neurology Research Office

Baltimore, Maryland, 21287, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Paramus, New Jersey, 07652, United States

Location

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

Guilford Neurologic Research Partners, LLC

Greensboro, North Carolina, 27401, United States

Location

Jefferson University Hospitals, Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Neurology Clinic - Cordova

Cordova, Tennessee, 38018, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic

Frisco, Texas, 75034, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Multiple Sclerosis Center of Tidewater

Norfolk, Virginia, 23502, United States

Location

Wheaton Franciscan Healthcare - St. Francis Outpatient Center

Milwaukee, Wisconsin, 53215, United States

Location

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Aga Khan University-Kenya.

Nairobi, 00100, Kenya

Location

Centro Internacional De Mercadeo

Guaynabo, 969, Puerto Rico

Location

Related Publications (1)

• Williams MJ, Okai AF, Cross AH, Monson NL, Vartanian T, Thrower BW, Reder AT, English JB, Wu GF, Bernitsas E, Yap S, Ndrio J, Pei J, Mowry EM, Magrini F, Acosta J, Amezcua L; CHIMES investigators. Demographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial. Mult Scler Relat Disord. 2023 Aug;76:104794. doi: 10.1016/j.msard.2023.104794. Epub 2023 Jun 9.

  PMID: 37356256 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 6, 2020
• Study Start: July 30, 2020
• Primary Completion: December 15, 2022
• Study Completion: November 11, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (26); KE (1); PR (1)