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Completed

NCT Number: NCT06588387

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Patients by Education Status

    Time frame: Baseline

    Education status included:

    • No studies
    • Primary education
    • Secondary education
    • Superior education
    • Unknown or missing

  2. Number of Patients by Working Status

    Time frame: Baseline

    Working status included:

    • Full-time
    • Part-time
    • Retired
    • Incapacity for work
    • Medical leave
    • Unemployed
    • Student
    • Unknown or missing

  3. Body Mass Index (BMI)

    Time frame: Baseline

  4. Number of Patients by Smoking Habit

    Time frame: Baseline

    Smoking habits included:

    • Non-smoker
    • Smoker
    • Ex-smoker
    • Unknown or missing

  5. Number of Patients by Alcohol Consumption

    Time frame: Baseline

    Alcohol consumption categories included:

    • High risk consumer
    • Low risk consumer
    • Teetotaler
    • Unknown or missing

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

    Time frame: Baseline

    Genotype variants included:

    • CYP2C9*1*1
    • CYP2C9*1*2
    • CYP2C9*1*3
    • CYP2C9*2*2
    • CYP2C9*2*3
    • Other

  7. Time Since Multiple Sclerosis (MS) Diagnosis

    Time frame: Baseline

  8. Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis

    Time frame: Baseline

  9. Number of Patients by Number of Relapses in the 12 Months Before Starting Siponimod Treatment

    Time frame: Baseline

  10. Number of Patients by Number of Relapses in the 24 Months Before Starting Siponimod Treatment

    Time frame: Baseline

  11. Number of Patients by Number of Gadolinium T1 (Gd-T1) Lesions 24 Months Before Starting Siponimod Treatment

    Time frame: Baseline

  12. Baseline Expanded Disability Status Scale (EDSS) Score at the Start of Siponimod Treatment

    Time frame: 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 neurological exam and 10 being death due to MS.

  13. Number of Patients With Cognitive Decline Diagnosis

    Time frame: Baseline

  14. EDSS Cognitive Subscale Score in Patients With Cognitive Decline

    Time frame: 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.

  15. Number of Patients by Comorbidity

    Time frame: Baseline

Secondary outcomes

  1. Number of Patients who Discontinued Siponimod Treatment

    Time frame: Up to 12 months

  2. Number of Patients by Type of Siponimod Treatment Discontinuation

    Time frame: Up to 12 months

    Treatment discontinuation categories included temporal and permanent discontinuation.

  3. Number of Patients by Reason for Temporal Discontinuation of Siponimod Treatment

    Time frame: Up to 12 months

  4. Number of Patients by Reason for Permanent Discontinuation of Siponimod Treatment

    Time frame: Up to 12 months

  5. Number of Patients Who Started a New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment

    Time frame: Up to 12 months

  6. Number of Patients by New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment

    Time frame: Up to 12 months

  7. Number of Patients Who Received Concomitant Treatment for Symptomatic Treatment of MS

    Time frame: Up to 12 months

  8. Number of Patients by Type of Concomitant Treatment Received for Symptomatic Treatment of MS

    Time frame: Up to 12 months

  9. Number of Patients by Maintenance Siponimod Dose

    Time frame: Up to 12 months

    Maintenance siponimod doses included 1 milligram (mg) and 2 mg.

  10. Number of Patients who Needed a Siponimod Dose Modification

    Time frame: Up to 12 months

  11. Number of Patients by Reason for Siponimod Dose Modification

    Time frame: Up to 12 months

  12. Number of Patients who Needed First Dose Observation

    Time frame: Day 1 of the 12-month observation period

  13. Number of Patients who Reported an Adverse Event During First Dose Observation

    Time frame: Day 1 of the 12-month observation period

  14. Number of Patients who Reported an Adverse Event During Treatment With Siponimod

    Time frame: Up to 12 months

  15. Number of Patients who Reported an Adverse Event of Special Interest During Treatment With Siponimod

    Time frame: 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

  16. Number of Patients who Reported a Serious Adverse Event During Treatment With Siponimod

    Time frame: Up to 12 months

  17. Number of Patients With Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment

    Time frame: Up to 12 months

  18. Number of Patients With Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment

    Time frame: Up to 12 months

  19. Number of Patients With Serious Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment

    Time frame: Up to 12 months

  20. Number of Patients With Serious Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment

    Time frame: Up to 12 months

  21. Number of Patients Who Died During Treatment With Siponimod

    Time frame: Up to 12 Months

  22. Number of Patients by Lymphopenia Grade During Treatment With Siponimod

    Time frame: 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

  23. Number of Patients With Confirmed Disability Progression During Treatment With Siponimod

    Time frame: 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.

    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 scores, ranging from 0 (normal) to 10 (death due to MS).

  24. Time to First Relapse

    Time frame: Up to 12 months

  25. Number of Patients Free From Relapses During the 12 Months of Treatment With Siponimod

    Time frame: 12 months

  26. Number of Patients With Radiologically Detected MS Disease Activity During Treatment With Siponimod

    Time frame: Up to 12 months

  27. Number of Patients With New Gd-T1 Lesions Detected After Treatment With Siponimod

    Time frame: Up to 12 months

  28. Number of Patients With New or Enhanced T2 Lesions Detected After Treatment With Siponimod

    Time frame: Up to 12 months

  29. Number of Patients With COVID-19 During the Study

    Time frame: Up to 12 months

  30. Number of Patients by COVID-19 Vaccination Status at the Moment of COVID-19 Infection

    Time frame: Up to 12 months

    Vaccination status included vaccinated and not vaccinated.

  31. Number of Patients who Required Hospitalization due to COVID-19 Infection During the Study

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Acronym: RESYZE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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