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NCT04377555CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 4 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
179 (actual)
First submitted
1 May 2020
Start date
30 Jul 2020
Primary completion date
15 Dec 2022
Lead sponsor
Genentech, Inc.
NCT number
NCT04377555

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 179
  • From 30 Jul 2020 to the primary completion date, 15 Dec 2022
  • 28 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab

Other illness

  • Infection Related
  • Cancer Related
  • Other Medical Conditions
  • Known presence or history of other neurologic disorders

Lab values

  • Laboratory: abnormalities or findings at screening

Other

  • 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
  • Pregnant or lactating, or intending to become pregnant during the study

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Aga Khan University-Kenya.
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NairobiKenyaUnknown status
Centro Internacional De Mercadeo
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GuaynaboPuerto RicoUnknown status
Atlanta Neuroscience Institute
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AtlantaUnited StatesUnknown status
Shepherd Center Inc.
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AtlantaUnited StatesUnknown status
Johns Hopkins University Neurology Research Office
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BaltimoreUnited StatesUnknown status
University of Maryland Medical Center
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BaltimoreUnited StatesUnknown status
Rush University Medical Center
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ChicagoUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Neurology Clinic - Cordova
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CordovaUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Wayne State University
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DetroitUnited StatesUnknown status
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
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FriscoUnited StatesUnknown status
Guilford Neurologic Research Partners, LLC
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GreensboroUnited StatesUnknown status
Baylor College of Medicine Medical Center
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HoustonUnited StatesUnknown status
Josephson Wallack Munshower Neurology, PC
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IndianapolisUnited StatesUnknown status
Baptist Neurology - Beaches
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Jacksonville BeachUnited StatesUnknown status
Keck School of Medicine of USC
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Los AngelesUnited StatesUnknown status
University of Miami Miller School of Medicine
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MiamiUnited StatesUnknown status
Froedtert and the Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Wheaton Franciscan Healthcare - St. Francis Outpatient Center
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MilwaukeeUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Multiple Sclerosis Center of Tidewater
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NorfolkUnited StatesUnknown status
Hackensack University Medical Center
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ParamusUnited StatesUnknown status
Jefferson University Hospitals, Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Barrow Neurological Institute
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PhoenixUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
SUNY Upstate Medical Center
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SyracuseUnited StatesUnknown status
Georgetown University Medical Center
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.