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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
179
Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
Barrow Neurological Institute
Phoenix, Arizona, United States
Keck School of Medicine of USC
Los Angeles, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Baptist Neurology - Beaches
Jacksonville Beach, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)
Time frame: 48 Weeks
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48
Time frame: Week 48
Time to protocol-defined event
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI
Time frame: Week 48
Annualized relapse rate at week 48
Time frame: Week 48
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Shepherd Center Inc.
Atlanta, Georgia, United States
Atlanta Neuroscience Institute
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, United States
...and 18 more locations