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.

Updated on 19 February 2024

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Summary

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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 Identifier	NCT04377555
Sponsor	Genentech, Inc.
Last Modified on	19 February 2024

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

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

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Study Definition

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