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

  • Autoimmune Disorder
  • Multiple Sclerosis (MS)
  • Neurodegenerative Disorder
  • Relapsing Multiple Sclerosis (RMS)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
  • Kenya
  • Puerto Rico
  • United States
Trial Identifier:

NCT04377555 ML42071

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      Trial Summary

      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.

      Genentech, Inc. Sponsor
      Phase 4 Phase
      NCT04377555,ML42071 Trial Identifier
      Ocrelizumab Treatments
      Multiple Sclerosis, Relapsing Condition
      Official Title

      An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 65 Years Age
      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

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