drugset / Trial / NCT04377555

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

NCT04377555

Phase 4 Completed 179 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-07-30
Primary completion
2022-12-15
Completion
2025-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody 600 mg Intravenous

Indications