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

• Status: Recruiting
• Trial end date: 2024-05-09
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Ocrelizumab

Criteria

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