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

Novartis

Status: Completed

Conditions: Secondary Progressive Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT06588387

CBAF312AES06

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with SPMS, as diagnosed by a physician, who started siponimod treatment at least 12 months before (during the start of the treatment period: from April 2021 to September 2022), regardless of whether they continued treatment or they did not.
• Patients who received at least 1 dose of siponimod treatment for SPMS with a 12-month observation period.
• Availability of the data for at least 12 months after siponimod initiation.

Exclusion criteria

• Patients with any contraindication to siponimod, according to applicable Summary of Product Characteristics (SmPC).
• Patients included in any clinical trial at any moment of the study period.

Trial design

210 participants in 1 patient group

Siponimod Cohort

Description:

Patients who received at least one dose of siponimod during the drug initiation period (April 2021 to September 2022).