NCT01194570

A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 735 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.

Conditions

• Multiple Sclerosis, Primary Progressive

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.
OTHER	Placebo	Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.

Timeline

• Start date: 2011-03-02
• Primary completion: 2015-07-23
• Completion: 2022-12-31
• First posted: 2010-09-03
• Last updated: 2024-01-10
• Results posted: 2017-12-26

Locations

184 sites across 29 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russia, Spain, Switzerland, Ukraine, United Kingdom