Mayzent (Siponimod) Onboarding of Secondary Progressive M... | NCT05826028

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

NCT05826028

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 24, 2023Actual

Enrollment

368Actual

Phase

Not provided

Conditions

Secondary Progressive Multiple Sclerosis

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2020Actual

Primary Completion Date

Apr 20, 2022Actual

Completion Date

Apr 20, 2022Actual

First Submitted Date

Apr 19, 2023

First Submission Date that Met QC Criteria

Apr 19, 2023

First Posted Date

Apr 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

Apr 24, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

368Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This was a retrospective, noninterventional cohort study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigational Site		Camperdown	New South Wales	2050	Australia
Novartis Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D020528	Multiple Sclerosis, Chronic Progressive

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided