Tolebrutinib in real-world MS care for patients treated by clinicians
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
Run by Sanofi · NCT07898371 · Data updated 2026-11-12
This real-world study sees how tolebrutinib is used for multiple sclerosis patients and what outcomes look like in everyday practice.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | tolebrutinib |
| Locations | 1 site (Marina, Abu Dhabi Emirate) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | September 21, 2031 |
| Study ends | October 1, 2031 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07898371 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with multiple sclerosis who are deciding to start tolebrutinib per local guidelines and who can provide informed consent.
✕Probably not a fit
Patients who do not choose to start tolebrutinib or who discontinue treatment early may not experience study-derived insights.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study describes how clinicians prescribe tolebrutinib in routine MS care and collects patient-reported outcomes and health care utilization data over time. Participation is voluntary and occurs only after a treatment decision has been made, without altering standard care. The study follows patients for up to five years, with about two years to enroll and three years of follow-up per patient. Data will come from medical records, patient reports, and routine care interactions. The study is sponsored by Sanofi and conducted at a single site in Abu Dhabi, reflecting real-world usage patterns across local guidelines.
Why it matters
Potential benefit: If successful, the study could clarify real-world effectiveness and patterns of tolebrutinib use to inform clinicians and patients.
How similar studies have gone: Real-world observational data have previously provided useful insights for MS therapies, though specific long-term tolebrutinib real-world data may be limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Participation in tolebrutinib long-term safety (LTS) study or any prior tolebrutinib study; experience with any other Bruton's Tyrosine Kinase (BTK) inhibitors. * 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.
Where it's running
-
Harley Street Medical Centre
Marina, Abu Dhabi Emirate, United Arab Emirates Recruiting
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.