ENSEMBLE

AN OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATETHE EFFECTIVENESS AND SAFETY OFOCRELIZUMAB IN PATIENTS WITH EARLY STAGERELAPSING REMITTING MULTIPLE SCLEROSIS

14/10/2017 to 14/10/2023

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in patients with early stage RRMS. The first dose of ocrelizumab will be administered as an initial dose of two 300-mg infusions (600 mg total) in 250 mL 0.9% sodium chloride each separated by 14 days (i.e., Days 1 and 15) followed by one 600-mg infusion in 500 mL 0.9% sodium chloride every 24 weeks for the remainder of the study duration.
The study will consist of the following periods:
· Screening period: Up to 4 weeks
· Treatment period: Open-label treatment period of 192 weeks (i.e. 24 weeks after the last dose of ocrelizumab, which will be administered at Week 168)
· A follow-up period of at least 48 weeks, which is independent of the disease modifying treatment (DMT) administered as explained below