Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05826028

Enrollment

368

Registered

2023-04-24

Start date

2020-07-09

Completion date

2022-04-20

Last updated

2023-04-24

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

Conditions

Secondary Progressive Multiple Sclerosis

Brief summary

This study was a retrospective, non-interventional, longitudinal, descriptive study. This study did not have a key underlying hypothesis, rather it was designed to explore the onboarding and adherence of SPMS patients in Australia to Mayzent (siponimod) treatment. Initiating siponimod involves pre-screen tests, including a CYP2C9 genotype test to determine siponimod maintenance dosing, and patients underwent a 6-day titration prior to maintenance. The MSGo platform was developed to support onboarding. It is an integrated digital platform that functions as a patient support service.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients with SPMS as per the treating physician's clinical assessment (Therapeutic Goods Administration \[TGA\]-approved indication of Mayzent). * Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 (inclusive). * Patients accessing Mayzent via the Mayzent Experience Program (MEP) must have met the MEP criteria, and if available, the Pharmaceutical Benefits Scheme (PBS) restrictions recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). * Patients accessing Mayzent via the PBS must have met the PBS restrictions.

Exclusion criteria

* Patients who were contraindicated for Mayzent treatment according to the TGA-approved Product Information. * Patients diagnosed with clinically isolated syndrome or primary progressive multiple sclerosis (MS).

Design outcomes

Primary

Measure	Time frame
Average time for siponimod onboarding	Up to 168 days

Secondary

Measure	Time frame
Time to siponimod onboarding in pre-specified sub-groups	Up to 168 days
Percentage of patients who adhered to the titration protocol	Up to 168 days
Time on maintenance therapy	Up to 168 days

Countries

Australia

Outcome results