Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 4
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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