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


Brief 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.


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-naïve 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 naïve 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

– 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

– 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


  • USC Keck School Of Medicine, Los Angeles, California, United States, 90033
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