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.
- Diseases
- Multiple sclerosis
- 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
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Aga Khan University-Kenya. Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
| Centro Internacional De Mercadeo Coordinator of this site? Confirm its status | Guaynabo | Puerto Rico | Unknown status |
| Atlanta Neuroscience Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Shepherd Center Inc. Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Johns Hopkins University Neurology Research Office Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Neurology Clinic - Cordova Coordinator of this site? Confirm its status | Cordova | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Wayne State University Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic Coordinator of this site? Confirm its status | Frisco | United States | Unknown status |
| Guilford Neurologic Research Partners, LLC Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Baylor College of Medicine Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Josephson Wallack Munshower Neurology, PC Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Baptist Neurology - Beaches Coordinator of this site? Confirm its status | Jacksonville Beach | United States | Unknown status |
| Keck School of Medicine of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Froedtert and the Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Wheaton Franciscan Healthcare - St. Francis Outpatient Center Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Multiple Sclerosis Center of Tidewater Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Paramus | United States | Unknown status |
| Jefferson University Hospitals, Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| SUNY Upstate Medical Center Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Georgetown University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.