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

Phase 4

Recruiting

• Conditions: Nervous System Diseases

• Registration Number: PACTR202103563404333
• Lead Sponsor: Genentech Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified