Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05826028




Registration number
NCT05826028
Ethics application status
Date submitted
19/04/2023
Date registered
24/04/2023
Date last updated
24/04/2023

Titles & IDs
Public title
Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo
Scientific title
Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo
Secondary ID [1] 0 0
CBAF312AAU02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary Progressive Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average time for siponimod onboarding
Timepoint [1] 0 0
Up to 168 days
Secondary outcome [1] 0 0
Time to siponimod onboarding in pre-specified sub-groups
Timepoint [1] 0 0
Up to 168 days
Secondary outcome [2] 0 0
Percentage of patients who adhered to the titration protocol
Timepoint [2] 0 0
Up to 168 days
Secondary outcome [3] 0 0
Time on maintenance therapy
Timepoint [3] 0 0
Up to 168 days

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/04/2022
Sample size
Target
Accrual to date
Final
368
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigational Site - St Leonards
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05826028
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05826028