About this trial
The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of RMS/PPMS in accordance with the revised 2017 McDonald Criteria
EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline
Documented MRI of brain with abnormalities consistent with MS before screening
Disqualifiers
Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)
History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)
Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)
History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
Trial design
Single group
Treatments tested in this trial
Ocrelizumab
DrugOcrelizumab will be administered as per the schedule specified in the respective arms.
Treatment groups
Trial outcomes
Primary outcomes
RMS Cohort: Annualized Protocol-defined Relapse Rate
PPMS Cohort: B-cell Levels in Blood
PPMS Cohort: Percentage of Participants Achieving Cluster of Differentiation 19 (CD19+) B-cell Levels of <10 Cells/Microliter (μL) at Week 48
Secondary outcomes
RMS Cohort: Percentage of Participants Who Have No Evidence of Disease Activity (NEDA3) During a 48-week Period
RMS Cohort: Percentage of Relapse-free Participants by Week 48
RMS Cohort: Percentage of Participants Who Have NEDA3 During a 24-week Period
RMS Cohort: Total Number of T1 Gadolinium (Gd)-enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI)
Sponsors and contacts
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