NCT07898371Recruiting
A Study to Describe Multiple Sclerosis Patients Treated With Tolebrutinib as Per Label in a Real-world Setting
A Multinational, Prospective, Observational Study to Describe Multiple Sclerosis (MS) Patients Treated With Tolebrutinib as Per Approved Local Label in a Real-world Setting
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 2 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 21 Sept 2031
- Lead sponsor
- Sanofi
- Diseases
- Multiple sclerosis
- NCT number
- NCT07898371
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 Oct 2026 to the primary completion date, 21 Sept 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in tolebrutinib long-term safety (LTS) study or any prior tolebrutinib study; experience with any other Bruton's Tyrosine Kinase (BTK) inhibitors.
Other
- Current or planned/pending participation in a clinical study.
- Inability to comply with the study protocol
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who the study is looking for
- Willing to participate with the ability to consent and sign an Informed Consent Form (ICF).
- Treatment decision according to approved local label. Retrospective inclusion of patients who had initiated tolebrutinib up to a maximum of 4 weeks prior to signing the ICF is allowed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harley Street Medical Centre Coordinator of this site? Confirm its status | Marina | United Arab Emirates | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.