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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    150
  • sponsor
    Genentech, Inc.
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Updated on 19 February 2024
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Summary

This is an open-label, multicenter study that includes a main study for all participants enrolled and an optional cerebrospinal fluid (CSF) sub-study. Self-identified African American (AA) and Hispanic or Latin American (HA) participants with a diagnosis of relapsing multiple sclerosis (RMS) will be enrolled. The treating neurologist must make an independent medical assessment and decision to initiate ocrelizumab treatment per label (USPI) as the most appropriate standard of care treatment for the participant. 150 participants will be enrolled in the main study (75 AA and 75 HA) and 50 participants will be enrolled in the CSF sub-study (25 AA and 25 HA). Participants will be assessed for disease activity and biomarkers of neuronal damage at baseline and during treatment with ocrelizumab.

Details
Condition Multiple Sclerosis, Relapsing
Age 18years - 65years
Treatment Ocrelizumab
Clinical Study IdentifierNCT04377555
SponsorGenentech, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
Participants who self-identify as African American or Hispanic/Latino American
Treatment-nave or initiating first switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethylfumarate (DMF); or siponimod; or fingolimod
Disease duration from the onset of MS symptoms: less than 15 years in participants with an EDSS >5.0 at screening
At least one clinically documented episode (for nave participants) or suboptimal response or intolerance to prior DMT (for switch participants) in the past year and/or at least one T1-weighted Gd-enhancing lesion in the past year and/or at least one new or expanding T2 lesion in the past year at the time of enrollment
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

Exclusion Criteria

Diagnosis of secondary progressive MS without relapses for at least 1 year
Primary Progressive Multiple Sclerosis (PPMS)
Known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
History of recurrent aspiration pneumonia requiring antibiotic therapy
History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy)
Known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit
History of cancer, including solid tumors and hematological malignancies
Pregnant or lactating, or intending to become pregnant during the study
History of or currently active primary or secondary immunodeficiency
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
History or known presence of systemic autoimmune disorders
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Significant, uncontrolled disease including congestive heart failure, uncontrolled hypertension, pulmonary, renal, hepatic, endocrine, gastrointestinal, or any other significant disease
Known presence or history of other neurologic disorders
Prior treatment with any disease modifying therapy for MS other than interferon or glatiramer acetate or dimethylfumarate (DMF); or siponimod; or fingolimod
Previous treatment with cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for MS
History of alcohol or other drug abuse within 24 weeks prior to enrollment
Vaccinations
Certain laboratory abnormalities or findings at Screening
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