Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588387
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
A Real-world Study to Assess the Use of Siponimod in Spain to Treat Patients With Secondary Progressive Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observational Retrospective Study to Assess the Use of Siponimod Mayzent on Patients With Secondary Progressive Multiple Sclerosis in Clinical Practice in Spain - RESYZE Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESYZE
Brief Summary:
RESYZE was a non-interventionalobservational retrospective multi-center study conducted in 28 public and private hospitals in Spain assessing secondary progressive multiple sclerosis SPMS patients in a real-world setting Patients underwent clinical assessments and received their standard routine medical care as determined by their treating physicians The study used secondary data ie electronic medical records EMR from hospitals Patients who met the eligibility criteria were selected from the EMR of each of the sites to include adult SPMS diagnosed patients who received at least one dose of siponimod during the start of treatment period between April 2021 and 01 September 2022 with a 12-month observation period regardless of whether or not they continued the treatment The study compiled data that was available in the hospital EMR from each patient up to 24 months before the first siponimod dose and 12 months after the first siponimod dose Data were collected for each patient at regular intervals of 612 months and within a window period of 45 days as available
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: