Clinical trial NCT06588387: A Real-world Study to Assess the Use of Siponimod in Spain to Treat Patients With Secondary Progressive Multiple Sclerosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Progressive Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients by Education Status
timeFrame: Baseline
measure: Number of Patients by Working Status
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Number of Patients by Smoking Habit
timeFrame: Baseline
measure: Number of Patients by Alcohol Consumption
timeFrame: Baseline
measure: Number of Patients by Cytochrome P450 Family 2 Subfamily C Member 9 (CYP2C9) Genotype
timeFrame: Baseline
measure: Time Since Multiple Sclerosis (MS) Diagnosis
timeFrame: Baseline
measure: Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis
timeFrame: Baseline
measure: Number of Patients by Number of Relapses in the 12 Months Before Starting Siponimod Treatment
timeFrame: Baseline
measure: Number of Patients by Number of Relapses in the 24 Months Before Starting Siponimod Treatment
timeFrame: Baseline
measure: Number of Patients by Number of Gadolinium T1 (Gd-T1) Lesions 24 Months Before Starting Siponimod Treatment
timeFrame: Baseline
measure: Baseline Expanded Disability Status Scale (EDSS) Score at the Start of Siponimod Treatment
timeFrame: Baseline
measure: Number of Patients With Cognitive Decline Diagnosis
timeFrame: Baseline
measure: EDSS Cognitive Subscale Score in Patients With Cognitive Decline
timeFrame: Baseline
measure: Number of Patients by Comorbidity
timeFrame: Baseline
Secondary outcomes:
measure: Number of Patients who Discontinued Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients by Type of Siponimod Treatment Discontinuation
timeFrame: Up to 12 months
measure: Number of Patients by Reason for Temporal Discontinuation of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients by Reason for Permanent Discontinuation of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients Who Started a New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients by New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients Who Received Concomitant Treatment for Symptomatic Treatment of MS
timeFrame: Up to 12 months
measure: Number of Patients by Type of Concomitant Treatment Received for Symptomatic Treatment of MS
timeFrame: Up to 12 months
measure: Number of Patients by Maintenance Siponimod Dose
timeFrame: Up to 12 months
measure: Number of Patients who Needed a Siponimod Dose Modification
timeFrame: Up to 12 months
measure: Number of Patients by Reason for Siponimod Dose Modification
timeFrame: Up to 12 months
measure: Number of Patients who Needed First Dose Observation
timeFrame: Day 1 of the 12-month observation period
measure: Number of Patients who Reported an Adverse Event During First Dose Observation
timeFrame: Day 1 of the 12-month observation period
measure: Number of Patients who Reported an Adverse Event During Treatment With Siponimod
timeFrame: Up to 12 months
measure: Number of Patients who Reported an Adverse Event of Special Interest During Treatment With Siponimod
timeFrame: Up to 12 months
measure: Number of Patients who Reported a Serious Adverse Event During Treatment With Siponimod
timeFrame: Up to 12 months
measure: Number of Patients With Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients With Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients With Serious Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients With Serious Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment
timeFrame: Up to 12 months
measure: Number of Patients Who Died During Treatment With Siponimod
timeFrame: Up to 12 Months
measure: Number of Patients by Lymphopenia Grade During Treatment With Siponimod
timeFrame: Baseline, Month 6, Month 12
measure: Number of Patients With Confirmed Disability Progression During Treatment With Siponimod
timeFrame: Up to 12 months
measure: Time to First Relapse
timeFrame: Up to 12 months
measure: Number of Patients Free From Relapses During the 12 Months of Treatment With Siponimod
timeFrame: 12 months
measure: Number of Patients With Radiologically Detected MS Disease Activity During Treatment With Siponimod
timeFrame: Up to 12 months
measure: Number of Patients With New Gd-T1 Lesions Detected After Treatment With Siponimod
timeFrame: Up to 12 months
measure: Number of Patients With New or Enhanced T2 Lesions Detected After Treatment With Siponimod
timeFrame: Up to 12 months
measure: Number of Patients With COVID-19 During the Study
timeFrame: Up to 12 months
measure: Number of Patients by COVID-19 Vaccination Status at the Moment of COVID-19 Infection
timeFrame: Up to 12 months
measure: Number of Patients who Required Hospitalization due to COVID-19 Infection During the Study
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: