Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsi… (NCT04377555) | Clinical Trial Compass
CompletedPhase 4
Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
United States179 participantsStarted 2020-07-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 o…
What they're measuring
1
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment