Relapsing Multiple SclerosisNCT06395909
A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis
An observational study of Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, run by Novartis at 1 site in United States.
Trial summary
This was a multicenter, non-interventional, retrospective study aiming to evaluate the real-world effectiveness and safety of siponimod treatment in Chinese patients with relapsing forms of multiple sclerosis (RMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2023to 31 Aug 2023
- 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
- Written informed consent if requested by local regulation.
- Patients had a diagnosis of RMS (including CIS, RRMS, or active SPMS).
- Chinese patients were 18 years or older at the index date.
- Patients had a minimum 3-month persistence on siponimod after the index date.
- Patients had at least one documented clinical visit in the observation period after the initiation of siponimod treatment.
Who cannot join
- Patients previously treated with siponimod (including participation in clinical trials) before the index date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World, Retrospective, Multicenter Study to Assess the Effectiveness and Safety of Mayzent® (Siponimod) in Chinese Patients With Relapsing Forms of Multiple Sclerosis
This was a multicenter, non-interventional, retrospective study aiming to evaluate the real-world effectiveness and safety of siponimod treatment in Chinese patients with relapsing forms of multiple sclerosis (RMS). The data were collected retrospectively through medical records review and abstraction conducted at a single time point per patient by the investigator's site staff or a designate (at the discretion of the site, if allowed by local regulations). There was no prospective patient follow-up for this study. Obtaining informed consent was based on local regulations. Where permissible, waivers could be applied to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) as appropriate, based on the retrospective collection of non-personally identifiable data, if acceptable per local regulations.
The target patient population included adult patients diagnosed with RMS (including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or active secondary progressive multiple sclerosis (SPMS)), and who received at least 3-months of treatment with siponimod after the index date. The index date is the date of siponimod initiation, defined as the date of first prescription record of siponimod in the patient's medical records with RMS diagnosis. Effectiveness data (i.e., clinical relapses, magnetic resonance imaging (MRI) activity) were collected from the index date, through the end of the observation period. The observation period was from the index date to the date of initiation of medical records abstraction at site, or patient withdrawal of consent, loss of follow-up, or death, whichever occurred first. Among patients who permanently discontinued siponimod during the observation period, safety data were collected up to 30 days after the last dose of siponimod.
- Conditions
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Siponimod cohort | Patients who were at least 18 years old diagnosed with clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or active secondary progressive multiple sclerosis and had received at least 3 months of siponimod treatment after the index date. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR)
The ARR was calculated using the total number of relapses (as documented in the patient's medical records) after index date divided by the total person days of follow-up after index date multiplied by 365.25.
Measured: Up to approximately 32 months
Secondary outcomes (4)
Proportion of Patients Relapse-free at 12 Months after Index Date
Measured: 12 months
Proportion of Patients Free of Magnetic Resonance Imaging (MRI) Activity at 12 Months after Index Date
Measured: 12 months
Proportion of Patients with Treatment-emergent Adverse Events (TEAEs), per Category
Categories were TEAEs, treatment-related TEAEs, serious TEAEs, TEAEs leading to discontinuation of siponimod, TEAEs leading to death, and TEAEs of special interest (AESIs).
TEAEs were defined as any AEs that were not presented prior to medical treatment, or an already presented event that worsens either in intensity or frequency following the treatment, that developed after siponimod initiation.
Measured: Up to approximately 32 months
Proportion of Patients with Selected Notable Abnormal Laboratory Data
Selected notable abnormal laboratory data included complete blood count with differential lymphocyte count and liver function tests.
Measured: Up to approximately 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start23 Apr 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395909
- Sponsor's protocol ID
- CBAF312A2413
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World, Retrospective, Multicenter Study to Assess the Effectiveness and Safety of Mayzent® (Siponimod) in Chinese Patients With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06395909
- Acronym / sponsor ID
- CBAF312A2413
- Conditions
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 2 May 2024 (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 was a multicenter, non-interventional, retrospective study aiming to evaluate the real-world effectiveness and safety of siponimod treatment in Chinese patients with relapsing forms of multiple sclerosis (RMS). The data were collected retrospectively through medical records review and abstraction conducted at a single time point per patient by the investigator's site staff or a designate (at the discretion of the site, if allowed by local regulations). There was no prospective patient follow-up for this study. Obtaining informed consent was based on local regulations. Where permissible, waivers could be applied to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) as appropriate, based on the retrospective collection of non-personally identifiable data, if acceptable per local regulations.
The target patient population included adult patients diagnosed with RMS (including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or active secondary progressive multiple sclerosis (SPMS)), and who received at least 3-months of treatment with siponimod after the index date. The index date is the date of siponimod initiation, defined as the date of first prescription record of siponimod in the patient's medical records with RMS diagnosis. Effectiveness data (i.e., clinical relapses, magnetic resonance imaging (MRI) activity) were collected from the index date, through the end of the observation period. The observation period was from the index date to the date of initiation of medical records abstraction at site, or patient withdrawal of consent, loss of follow-up, or death, whichever occurred first. Among patients who permanently discontinued siponimod during the observation period, safety data were collected up to 30 days after the last dose of siponimod.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siponimod cohort | – | –Patients who were at least 18 years old diagnosed with clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or active secondary progressive multiple sclerosis and had received at least 3 months of siponimod treatment after the index date. |
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 (5 listed)
- Written informed consent if requested by local regulation.
- Patients had a diagnosis of RMS (including CIS, RRMS, or active SPMS).
- Chinese patients were 18 years or older at the index date.
- Patients had a minimum 3-month persistence on siponimod after the index date.
- Patients had at least one documented clinical visit in the observation period after the initiation of siponimod treatment.
Key exclusion criteria (1 listed)
- Patients previously treated with siponimod (including participation in clinical trials) before the index date.
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
Annualized Relapse Rate (ARR)
Time frame: Up to approximately 32 months
The ARR was calculated using the total number of relapses (as documented in the patient's medical records) after index date divided by the total person days of follow-up after index date multiplied by 365.25.
4 secondary outcomes
Proportion of Patients Relapse-free at 12 Months after Index Date
Time frame: 12 months
Proportion of Patients Free of Magnetic Resonance Imaging (MRI) Activity at 12 Months after Index Date
Time frame: 12 months
Proportion of Patients with Treatment-emergent Adverse Events (TEAEs), per Category
Time frame: Up to approximately 32 months
Proportion of Patients with Selected Notable Abnormal Laboratory Data
Time frame: Up to approximately 32 months
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 2 May 2024.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, run by Novartis at 1 site in United States.
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 5 inclusion and 1 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 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Annualized Relapse Rate (ARR) (time frame: Up to approximately 32 months). 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 2 May 2024.