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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05826028
Collaborator
(none)
368
Enrollment
2
Locations
21.4
Actual Duration (Months)
184
Patients Per Site
8.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    368 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo
    Actual Study Start Date :
    Jul 9, 2020
    Actual Primary Completion Date :
    Apr 20, 2022
    Actual Study Completion Date :
    Apr 20, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Average time for siponimod onboarding [Up to 168 days]

    Secondary Outcome Measures

    1. Time to siponimod onboarding in pre-specified sub-groups [Up to 168 days]

    2. Percentage of patients who adhered to the titration protocol [Up to 168 days]

    3. Time on maintenance therapy [Up to 168 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigational Site Camperdown New South Wales Australia 2050
    2 Novartis Investigational Site St Leonards New South Wales Australia 2065

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05826028
    Other Study ID Numbers:
    • CBAF312AAU02
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    Apr 24, 2023
    Last Verified:
    Apr 1, 2023
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Multiple Sclerosis
    Multiple Sclerosis, Chronic Progressive
    Sclerosis

    Study Results

    No Results Posted as of Apr 24, 2023