A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate
efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV)
infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose
Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon
positive primary results after the double-blind phase, an optional higher dose extension
treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for
approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter.
Participants whose B-cell levels still did not replete to their baseline level or the lower
limit of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase
following the safety follow-up phase. The study will end when all participants who were not
treated with an alternative B-cell depleting therapy have repleted their B-cells to the
baseline value or the lower limit of normal.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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