NCT03593590

Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,710 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.

Timeline

• Start date: 2018-11-12
• Primary completion: 2026-01-19
• Completion: 2026-01-19
• First posted: 2018-07-20
• Last updated: 2026-02-17

Locations

158 sites across 25 countries: Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Dominican Republic, Egypt, Italy, Kuwait, Montenegro, Netherlands, Paraguay, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Turkey (Türkiye), United Arab Emirates, United Kingdom