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A Study to Describe Multiple Sclerosis Patients Treated With Tolebrutinib as Per Label in a Real-world Setting
Sponsor: Sanofi
Summary
This study aims to assess the real-world treatment patterns, data from patient reported outcomes, the effectiveness profile of tolebrutinib, and health care utilization data in routine practice. The decision to initiate tolebrutinib treatment is made by the treating neurologist as part of standard of care. Consideration and option of participation in the study will only be done once the treatment decision has been made, independent of study participation. Only upon signing the informed consent form (ICF) will the patient be enrolled in the study. The patient's participation in the study will not influence the MS treatment. Total study duration of study is 5 years per country comprising an approximately 24-months of enrollment period followed by a 36-month individual observational period.
Official title: A Multinational, Prospective, Observational Study to Describe Multiple Sclerosis (MS) Patients Treated With Tolebrutinib as Per Approved Local Label in a Real-world Setting
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2026-10-01
Completion Date
2031-10-01
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Tolebrutinib
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Locations (1)
Harley Street Medical Centre
Marina, Abu Dhabi Emirate, United Arab Emirates