A Phase III, Multicentre, Randomized, Parallel-Group, Double Blinded, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis
Location(s): United States
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in patients with primary progressive multiple sclerosis. Eligible patients will be randomized 2 : 1 to receive either ocrelizumab (300 mg intravenously, 2 infusions separated by 14 days in each treatment cycle) or placebo. The blinded treatment period will be at least 120 weeks, followed by open label treatment for patients in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Anticipated time on study treatment is up to 5.5 years.