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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

368 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-09

Study Completion Date

2022-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis

NCT06395909

Relapsing Multiple Sclerosis Clinically Isolated Syndrome Relapsing Remitting Multiple Sclerosis +1 more

COMPLETED

Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy

NCT05376579

Active Secondary Progressive Multiple Sclerosis

COMPLETED

Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study

NCT04895202

Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity

TERMINATED

Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients

NCT03623243

Multiple Sclerosis Relapsing Multiple Sclerosis Advancing Multiple Sclerosis

COMPLETED PHASE3

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

NCT04593927

Secondary Progressive Multiple Sclerosis (SPMS)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Progressive Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No