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

Completed · Phase 4

Conditions studied: Multiple Sclerosis, Relapsing

In brief

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.

Key facts

Study ID

NCT04377555

Run by

Genentech, Inc.

People needed

179

Starts

2020-07-30

Expected to finish

2025-11-11

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Barrow Neurological Institute — 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 — Paramus, New Jersey, United States
• SUNY Upstate Medical Center — Syracuse, New York, United States
• Guilford Neurologic Research Partners, LLC — Greensboro, North Carolina, 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
• Wheaton Franciscan Healthcare - St. Francis Outpatient Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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