Secondary Progressive Multiple SclerosisNCT05826028
Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo
An observational study of Secondary Progressive Multiple Sclerosis, run by Novartis Pharmaceuticals at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- How many people
- 368 participants
- Where
- 2 sitesAustralia
- Study dates
- 9 Jul 2020to 20 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Novartis Investigational Site
Camperdown, New South Wales, 2050
Novartis Investigational Site
St Leonards, New South Wales, 2065
About this study
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
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time for siponimod onboarding
Measured: Up to 168 days
Secondary outcomes (3)
Time to siponimod onboarding in pre-specified sub-groups
Measured: Up to 168 days
Percentage of patients who adhered to the titration protocol
Measured: Up to 168 days
Time on maintenance therapy
Measured: Up to 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start9 Jul 2020
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826028
- Sponsor's protocol ID
- CBAF312AAU02
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo
- ClinicalTrials.gov ID
- NCT05826028
- Acronym / sponsor ID
- CBAF312AAU02
- Conditions
- Secondary Progressive Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average time for siponimod onboarding
Time frame: Up to 168 days
3 secondary outcomes
Time to siponimod onboarding in pre-specified sub-groups
Time frame: Up to 168 days
Percentage of patients who adhered to the titration protocol
Time frame: Up to 168 days
Time on maintenance therapy
Time frame: Up to 168 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Progressive Multiple Sclerosis, run by Novartis Pharmaceuticals at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average time for siponimod onboarding (time frame: Up to 168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.