Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
48 Weeks
Disability progressionRelapsesMRI lesions
Other measures (3)
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48
Week 48
Disability progressionTime to protocol-defined event
Week 48
Disability progressionRelapsesMRI lesionsAnnualized relapse rate at week 48
Week 48
Relapses
Who could take part
Relapsing MS · 18 to 65
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Two Years of Ocrelizumab Treatment in Black and Hispanic People with Multiple Sclerosis in CHIMES: A Single-Arm Clinical Trial.Ann Neurol · 2026
Results
Demographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial.Mult Scler Relat Disord · 2023
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History
Started
Jul 2020
Main results due
Dec 2022
Finished
Nov 2025
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