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OpenTrials
Completed

NCT Number: NCT04377555

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. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.

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Key information

Conditions

Multiple Sclerosis, Relapsing Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Aga Khan University-Kenya., Nairobi, Kenya

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

Drug

Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.

Primary outcomes

  1. 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 outcomes

  1. Time to onset of 24 weeks confirmed disability progression (CDP) at week 48

    Time frame: Week 48

  2. 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

  3. Annualized relapse rate at week 48

    Time frame: Week 48

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
May 6, 2020
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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