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RECRUITING
NCT07898371

A Study to Describe Multiple Sclerosis Patients Treated With Tolebrutinib as Per Label in a Real-world Setting

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Interventions

DRUG

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