Protocol Number; CBAF312A1401

Long term special drug use-results surveillance for Mayzent in SPMS patients (prevention of relapses and prevention of physical disability progression in secondary progressive multiple sclerosis , CBAF312A1401)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031200377

Enrollment

330

Registered

2021-03-01

Start date

2020-09-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

secondary progressive multiple sclerosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients using Mayzent for the following indication for a specified post-marketing period of time Indication: prevention of secondary progressive multiple sclerosis recurrences and prevention of physical disability progression

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
1.Incidence of adverse events between the start of Mayzent administration and 24 months (720 days) on Mayzent 2. Incidence of serious adverse events between the start of Mayzent administration and 24 months (720 days) on Mayzent 3. Incidence of adverse reactions between the start of Mayzent administration and 24 months (720 days) on Mayzent	—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120003293

Outcome results