NCT06588387

A Real-world Study to Assess the Use of Siponimod in Spain to Treat Patients With Secondary Progressive Multiple Sclerosis

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
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RESYZE was a non-interventional/observational, 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 i.e., 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 6/12 months and within a window period of ±45 days, as available.

Conditions

• Secondary Progressive Multiple Sclerosis

Timeline

• Start date: 2022-11-03
• Primary completion: 2023-09-08
• Completion: 2023-09-08
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States