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Clinical trial

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)

ID
Name
CBAF312A1401
Description
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.
Trial arms
Trial start
2020-10-28
Estimated PCD
2023-08-30
Trial end
2023-08-30
Status
Completed
Treatment
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.
Arms:
Mayzent
Size
451
Primary endpoint
Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions
24 months
Eligibility criteria
Inclusion Criteria: * Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis Exclusion Criteria: -
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 451, 'type': 'ACTUAL'}}
Updated at
2024-02-12

1 organization

1 product

1 indication

Organization
Novartis Pharmaceuticals
Product
Mayzent
Indication
Secondary Progressive Multiple Sclerosis