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

NCT06588387 | Completed

• 1 other identifier: CBAF312AES06
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (15)

• Number of Patients by Education Status

  Education status included: * No studies * Primary education * Secondary education * Superior education * Unknown or missing

  Baseline

• Number of Patients by Working Status

  Working status included: * Full-time * Part-time * Retired * Incapacity for work * Medical leave * Unemployed * Student * Unknown or missing

  Baseline

• Body Mass Index (BMI)

  Baseline

• Number of Patients by Smoking Habit

  Smoking habits included: * Non-smoker * Smoker * Ex-smoker * Unknown or missing

  Baseline

• Number of Patients by Alcohol Consumption

  Alcohol consumption categories included: * High risk consumer * Low risk consumer * Teetotaler * Unknown or missing

  Baseline

• Number of Patients by Cytochrome P450 Family 2 Subfamily C Member 9 (CYP2C9) Genotype

  Genotype variants included: * CYP2C9\*1\*1 * CYP2C9\*1\*2 * CYP2C9\*1\*3 * CYP2C9\*2\*2 * CYP2C9\*2\*3 * Other

  Baseline

• 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

  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 neurological exam and 10 being death due to MS.

  Baseline

• Number of Patients With Cognitive Decline Diagnosis

  Baseline

• EDSS Cognitive Subscale Score in Patients With Cognitive Decline

  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.

  Baseline

• Number of Patients by Comorbidity

  Baseline

Secondary Outcomes (31)

• Number of Patients who Discontinued Siponimod Treatment

  Up to 12 months

• Number of Patients by Type of Siponimod Treatment Discontinuation

  Up to 12 months

• 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

Study Arms (1)

Siponimod Cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: November 3, 2022
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)