NCT03523858

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 927 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Conditions

• Progressive Multiple Sclerosis (PMS)

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)

Timeline

• Start date: 2018-05-28
• Primary completion: 2026-11-12
• Completion: 2026-11-12
• First posted: 2018-05-14
• Last updated: 2026-01-30

Locations

124 sites across 24 countries: United States, Bosnia and Herzegovina, Brazil, Canada, Colombia, Costa Rica, Czechia, Denmark, Egypt, France, Germany, Guatemala, Hungary, Ireland, Italy, Lebanon, Mexico, Morocco, Netherlands, Panama, Poland, Russia, Spain, United Arab Emirates

Regulatory

• FDA-regulated drug study