Multiple Sclerosis Clinical Trial
Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab.
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.
Eligibility Criteria
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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There are 31 Locations for this study
Phoenix Arizona, 85013, United States
Phoenix Arizona, 85032, United States
Los Angeles California, 90033, United States
Washington District of Columbia, 20007, United States
Jacksonville Beach Florida, 32250, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30327, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46256, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21205, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
Greensboro North Carolina, 27401, United States
Cincinnati Ohio, 45219, United States
Philadelphia Pennsylvania, 19107, United States
Cordova Tennessee, 38018, United States
Nashville Tennessee, 37212, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Plano Texas, 75024, United States
Norfolk Virginia, 23502, United States
Seattle Washington, 98122, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Nairobi , 00100, Kenya
Guaynabo , 969, Puerto Rico
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