NCT04593927

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 451 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 99 Years
• Healthy volunteers: Not accepted

Summary

This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.

Detailed description

This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.

Conditions

• Secondary Progressive Multiple Sclerosis (SPMS)

Interventions

Type	Name	Description
DRUG	Mayzent	There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.

Timeline

• Start date: 2020-10-28
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2020-10-20
• Last updated: 2024-02-12

Locations

174 sites across 1 country: Japan