A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis

Novartis

Status: Completed

Conditions: Secondary Progressive Multiple Sclerosis; Relapsing Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Clinically Isolated Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT06395909

CBAF312A2413

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

113 participants in 1 patient group

Siponimod cohort

Description:

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.