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

NCT ID: NCT04377555

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2025-12-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ocrelizumab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Center for Neurology and Spine - Phoenix - Hunt - PPDS

Phoenix, Arizona, United States

Keck School of Medicine of USC

Los Angeles, California, United States

Georgetown University Medical Center

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

Baptist Neurology - Beaches

Jacksonville Beach, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Shepherd Center Inc.

Atlanta, Georgia, United States

Atlanta Neuroscience Institute

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins University Neurology Research Office

Baltimore, Maryland, United States

Wayne State University

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Weill Cornell Medical College

New York, New York, United States

SUNY Upstate Medical Center

Syracuse, New York, United States

Guilford Neurologic Research Partners, LLC

Greensboro, North Carolina, United States

Neurology Specialists, Inc

Dayton, Ohio, United States

Jefferson University Hospitals, Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Neurology Clinic - Cordova

Cordova, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic

Frisco, Texas, United States

Baylor College of Medicine Medical Center

Houston, Texas, United States

Multiple Sclerosis Center of Tidewater

Norfolk, Virginia, United States

Swedish Neuroscience Institute

Seattle, Washington, United States

Wheaton Franciscan Healthcare - St. Francis Outpatient Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Aga Khan University Hospital

Nairobi, , Kenya

Centro Internacional De Mercadeo

Guaynabo, , Puerto Rico

Countries

United States; Kenya; Puerto Rico

References

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.

Reference Type: DERIVED

PMID: 37356256 (View on PubMed)

Other Identifiers

ML42071

Identifier Type: -

Identifier Source: org_study_id