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

April 19, 2023 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

368

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novartis Investigational Site
      • St Leonards, New South Wales, Australia, 2065
        • Novartis Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average time for siponimod onboarding
Time Frame: Up to 168 days
Up to 168 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBAF312AAU02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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