Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395909
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-28
Brief Title:
A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis
Sponsor:
Novartis
Organization:
Novartis
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 investigators 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 patients medical records with RMS diagnosis Effectiveness data ie 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
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 patients medical records with RMS diagnosis Effectiveness data ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None