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

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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202103563404333

Enrollment

150

Registered

2021-03-10

Start date

2020-07-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous System Diseases

Interventions

Ocrelizumab

Not Applicable

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment [ Time Frame: 48 Weeks ] A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)	—

Secondary

Measure	Time frame
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 [ Time Frame: Week 48 ];Time to protocol-defined event [ Time Frame: Week 48 ] A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI;Annualized relapse rate at week 48 [ Time Frame: Week 48 ]	—

Measure

Time frame

Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 [ Time Frame: Week 48 ];Time to protocol-defined event [ Time Frame: Week 48 ] A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI;Annualized relapse rate at week 48 [ Time Frame: Week 48 ]

—

Countries

Kenya

Contacts

Public ContactHuwaida Bulhan

Clinical Operations and RWD Lead

Huwaida.Bulhan@roche.com+254780888997

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026