Status:
ACTIVE_NOT_RECRUITING
Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
Lead Sponsor:
Genentech, Inc.
Conditions:
Multiple Sclerosis, Relapsing
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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/La...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2025
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04377555
Start Date
July 30 2020
End Date
December 29 2025
Last Update
November 17 2025
Active Locations (32)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Center for Neurology and Spine - Phoenix - Hunt - PPDS
Phoenix, Arizona, United States, 85032
3
Keck School of Medicine of USC
Los Angeles, California, United States, 90033-5315
4
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007