Clinical trial NCT06395909: A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Relapsing Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-05-02
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief 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). 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.


Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

• Patients previously treated with siponimod (including participation in clinical trials) before the index date.

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Up to approximately 32 months
Secondary outcomes:
measure: Proportion of Patients Relapse-free at 12 Months after Index Date
timeFrame: 12 months
measure: Proportion of Patients Free of Magnetic Resonance Imaging (MRI) Activity at 12 Months after Index Date
timeFrame: 12 months
measure: Proportion of Patients with Treatment-emergent Adverse Events (TEAEs), per Category
timeFrame: Up to approximately 32 months
measure: Proportion of Patients with Selected Notable Abnormal Laboratory Data
timeFrame: Up to approximately 32 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: