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

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Genentech

Status and phase

Active, not recruiting
Phase 4

Conditions

Multiple Sclerosis, Relapsing

Treatments

Drug: Ocrelizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04377555
ML42071

Details and patient eligibility

About

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.

Enrollment

179 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

179 participants in 1 patient group

All Participants
Experimental group
Description:
Main study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72.
Treatment:
Drug: Ocrelizumab

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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