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Completed

NCT Number: NCT05826028

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigational Site, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Average time for siponimod onboarding

    Time frame: Up to 168 days

Secondary outcomes

  1. Time to siponimod onboarding in pre-specified sub-groups

    Time frame: Up to 168 days

  2. Percentage of patients who adhered to the titration protocol

    Time frame: Up to 168 days

  3. Time on maintenance therapy

    Time frame: Up to 168 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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