CompletedPhase 4Relapsing MSNCT04377555

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

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 progression
  • Time to protocol-defined event

    Week 48

    Disability progressionRelapsesMRI lesions
  • Annualized 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

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Related trials

History

    1. Started

      Jul 2020

    2. Main results due

      Dec 2022

    3. Finished

      Nov 2025

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