NCT05269004

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Timeline

• Start date: 2022-05-03
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2022-03-07
• Last updated: 2026-02-02

Locations

234 sites across 37 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study