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

NCT06395909 | Completed

• 1 other identifier: CBAF312A2413
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 32 months

Secondary Outcomes (4)

• Proportion of Patients Relapse-free at 12 Months after Index Date

  12 months

• Proportion of Patients Free of Magnetic Resonance Imaging (MRI) Activity at 12 Months after Index Date

  12 months

• Proportion of Patients with Treatment-emergent Adverse Events (TEAEs), per Category

  Up to approximately 32 months

• Proportion of Patients with Selected Notable Abnormal Laboratory Data

  Up to approximately 32 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 2, 2024
• Study Start: April 23, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-05

Locations

US (1)