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NCT05826028 Clinical Trial

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

Secondary Progressive Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05826028
Other study ID # CBAF312AAU02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 9, 2020
Est. completion date April 20, 2022

Study information
Verified date April 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 368
Est. completion date April 20, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Novartis Investigational Site Camperdown New South Wales
Australia Novartis Investigational Site St Leonards New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average time for siponimod onboarding Up to 168 days
Secondary Time to siponimod onboarding in pre-specified sub-groups Up to 168 days
Secondary Percentage of patients who adhered to the titration protocol Up to 168 days
Secondary Time on maintenance therapy Up to 168 days
See also
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