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

NCT05826028 | Completed

• 1 other identifier: CBAF312AAU02
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 2

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.

Conditions

Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Average time for siponimod onboarding

  Up to 168 days

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

Novartis Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: April 24, 2023
• Study Start: July 9, 2020
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

AU (2)