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

Completed

• Conditions: Secondary Progressive Multiple Sclerosis

• Registration Number: NCT06588387
• Lead Sponsor: Novartis

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...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-11-03
• Primary Completion: 2023-09-08
• Study Completion: 2023-09-08
• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients by Education Status	Baseline	Education status included: * No studies; * Primary education; * Secondary education; * Superior education; * Unknown or missing
Number of Patients by Working Status	Baseline	Working status included: * Full-time; * Part-time; * Retired; * Incapacity for work; * Medical leave; * Unemployed; * Student; * Unknown or missing
Body Mass Index (BMI)	Baseline
Number of Patients by Smoking Habit	Baseline	Smoking habits included: * Non-smoker; * Smoker; * Ex-smoker; * Unknown or missing
Number of Patients by Alcohol Consumption	Baseline	Alcohol consumption categories included: * High risk consumer; * Low risk consumer; * Teetotaler; * Unknown or missing
Number of Patients by Cytochrome P450 Family 2 Subfamily C Member 9 (CYP2C9) Genotype	Baseline	Genotype variants included: * CYP2C9\*1\*1; * CYP2C9\*1\*2; * CYP2C9\*1\*3; * CYP2C9\*2\*2; * CYP2C9\*2\*3; * Other
Time Since Multiple Sclerosis (MS) Diagnosis	Baseline
Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis	Baseline
Number of Patients by Number of Relapses in the 12 Months Before Starting Siponimod Treatment	Baseline
Number of Patients by Number of Relapses in the 24 Months Before Starting Siponimod Treatment	Baseline
Number of Patients by Number of Gadolinium T1 (Gd-T1) Lesions 24 Months Before Starting Siponimod Treatment	Baseline
Baseline Expanded Disability Status Scale (EDSS) Score at the Start of Siponimod Treatment	Baseline	The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS score. The scale ranges from 0 to 10, with 0 being normal neurologica...
Number of Patients With Cognitive Decline Diagnosis	Baseline
EDSS Cognitive Subscale Score in Patients With Cognitive Decline	Baseline	The EDSS cognitive subscale is used to grade the decrease in mentation inside the Cerebral Functional System of the EDSS scale. The scale ranges from 0 to 5, with 0 being normal (no decrease in mentation) and 5 being dementia, confusion and/or complete disorientation.
Number of Patients by Comorbidity	Baseline

Secondary Outcome Measures

Name	Time	Method
Number of Patients who Discontinued Siponimod Treatment	Up to 12 months
Number of Patients by Type of Siponimod Treatment Discontinuation	Up to 12 months	Treatment discontinuation categories included temporal and permanent discontinuation.
Number of Patients by Reason for Temporal Discontinuation of Siponimod Treatment	Up to 12 months
Number of Patients by Reason for Permanent Discontinuation of Siponimod Treatment	Up to 12 months
Number of Patients Who Started a New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment	Up to 12 months
Number of Patients by New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment	Up to 12 months
Number of Patients Who Received Concomitant Treatment for Symptomatic Treatment of MS	Up to 12 months
Number of Patients by Type of Concomitant Treatment Received for Symptomatic Treatment of MS	Up to 12 months
Number of Patients by Maintenance Siponimod Dose	Up to 12 months	Maintenance siponimod doses included 1 milligram (mg) and 2 mg.
Number of Patients who Needed a Siponimod Dose Modification	Up to 12 months
Number of Patients by Reason for Siponimod Dose Modification	Up to 12 months
Number of Patients who Needed First Dose Observation	Day 1 of the 12-month observation period
Number of Patients who Reported an Adverse Event During First Dose Observation	Day 1 of the 12-month observation period
Number of Patients who Reported an Adverse Event During Treatment With Siponimod	Up to 12 months
Number of Patients who Reported an Adverse Event of Special Interest During Treatment With Siponimod	Up to 12 months	Adverse events of special interest included: * Lymphopenia; * Macular edema; * Bradyarrhythmia; * Atrioventricular blockage; * Hypertension; * Hepatic enzymes elevation; * Epileptic crisis; * Infections; * Cutaneous neoplasia; * COVID-19; * Death; * Other
Number of Patients who Reported a Serious Adverse Event During Treatment With Siponimod	Up to 12 months
Number of Patients With Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment	Up to 12 months
Number of Patients With Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment	Up to 12 months
Number of Patients With Serious Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment	Up to 12 months
Number of Patients With Serious Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment	Up to 12 months
Number of Patients Who Died During Treatment With Siponimod	Up to 12 Months
Number of Patients by Lymphopenia Grade During Treatment With Siponimod	Baseline, Month 6, Month 12	Lymphopenia grades: * Grade 1: less than lower limit of normal to 800 cells per cubic millimeters (cells/mm\^3); * Grade 2: less than 800 to 500 cells/mm\^3; * Grade 3: less than 500 to 200 cells/mm\^3; * Grade 4: less than 200 cells/mm\^3
Number of Patients With Confirmed Disability Progression During Treatment With Siponimod	Up to 12 months	Confirmed Disability Progression was determined by an increase of at least 1 point in the Expanded Disability Status (EDSS) score if the baseline EDSS was 5.5 or less, or an increase of 0.5 points in the EDSS score if the baseline EDSS score was greater than 5.5 confirmed in a second visit performed at least 3 months apart.; ...
Time to First Relapse	Up to 12 months
Number of Patients Free From Relapses During the 12 Months of Treatment With Siponimod	12 months
Number of Patients With Radiologically Detected MS Disease Activity During Treatment With Siponimod	Up to 12 months
Number of Patients With New Gd-T1 Lesions Detected After Treatment With Siponimod	Up to 12 months
Number of Patients With New or Enhanced T2 Lesions Detected After Treatment With Siponimod	Up to 12 months
Number of Patients With COVID-19 During the Study	Up to 12 months
Number of Patients by COVID-19 Vaccination Status at the Moment of COVID-19 Infection	Up to 12 months	Vaccination status included vaccinated and not vaccinated.
Number of Patients who Required Hospitalization due to COVID-19 Infection During the Study	Up to 12 months

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States