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Completed

NCT Number: NCT07168694

A Real-world Study About the Impact of Siponimod Treatment on Secondary Progressive Multiple Sclerosis Patients in Russia

The main aim of the study was to describe the demographic and clinical characteristics of patients with secondary progressive multiple sclerosis (SPMS) who were receiving siponimod therapy in Russia. This study analyzed data from outpatient records/medical records collected across 11 Russian multiple sclerosis (MS) centers. Data collection was carried out from April 16, 2024 to September 26, 2024.

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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

  • Documented diagnosis of SPMS, with or without relapses.
  • Treatment with siponimod for at least 6 months.

Exclusion criteria

None.

Treatment and study plan

Primary outcomes

  1. Demographics: Number of Patients by Age

    Time frame: Baseline

  2. Demographics: Number of Patients by Gender

    Time frame: Baseline

  3. Time Between MS Diagnosis and Treatment Initiation

    Time frame: Baseline

  4. Time Between SPMS Diagnosis and Treatment Initiation

    Time frame: Baseline

  5. Time Between First Symptoms and Treatment Initiation

    Time frame: Baseline

  6. Number of Patients by Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristics included:

    • MS symptoms
    • Magnetic resonance imaging (MRI) performed (yes/no)
    • Number of contrast-enhancing lesions on T1-weighted images (WI) (Gd+T1 lesions): absent, single, or multiple lesions
    • CYP2C9 isoenzyme genotype

  7. Number of Patients Categorized by Type of Treatment Received Before Initiation of Siponimod

    Time frame: Baseline

    Treatment categories included glucocorticosteroids, cytostatics, and disease-modifying treatments (DMTs).

  8. Number of Patients by DMT Received Before Initiation of Siponimod

    Time frame: Baseline

  9. Duration of the Washout Period After Other DMTs and Before Initiation of Siponimod

    Time frame: Baseline

  10. Number of Patients by Reason for Switching From Other DMTs to Siponimod

    Time frame: Baseline

  11. Duration of Siponimod Therapy

    Time frame: Up to 2 years

Secondary outcomes

  1. Change From Baseline in Expanded Disability Status Scale (EDSS) Score

    Time frame: Baseline and Months 6, 12, 18, 24

    The EDSS is a tool used by doctors to measure disability in MS patients and monitor changes in the level of disability over time. It focuses on rating 7 functional systems: visual function, brainstem symptoms (speech, swallowing, rapid eye movement), pyramidal (muscle strength and movement), cerebellar (coordination and balance), sensory, bowel and bladder function, and higher cerebral functions (thinking and memory). These ratings are then used in conjunction with observations and information concerning gait and use of assistive devices to rate the EDSS. EDSS scores range from 0 (normal) up to 10 (death due to MS).

  2. Percentage of Patients With Confirmed Disability Progression Over 6 Months (6m-CDP) Based on the EDSS Score

    Time frame: Months 6, 12, 18, 24

    Confirmed disability progression is determined when a patient shows a sustained or increased EDSS score compared to the date of the first documented worsening of neurological function, assessed at least 6 months later, provided there are no relapses during the assessment period. A clinically meaningful worsening of neurological function is defined as an increase in EDSS score of 1.5 points for patients with a baseline EDSS of 0, 1.0 point for those with a baseline EDSS of 1.0 to 5.5, or 0.5 points for patients with a baseline EDSS of 6.0.

  3. Number of Patients With MS Relapses

    Time frame: Baseline

  4. Annualized Relapse Rate (ARR)

    Time frame: 1 and 2 years before siponimod initiation and 6, 12, 18, and 24 months after siponimod treatment

  5. Change in ARR From 1 Year Before Siponimod Initiation to 6, 12, 18, and 24 Months After Siponimod Treatment

    Time frame: 1 year before siponimod initiation and 6, 12, 18, and 24 months after siponimod treatment

  6. Number of Patients With MRI Signs of MS After Siponimod Treatment

    Time frame: Months 6, 12, 18, 24

    MRI signs included:

    • Contrast-enhancing lesions on T1-WI (Gd+T1 lesions): absent, single, or multiple lesions
    • New/enlarged lesions on T2-WI or contrast-enhancing lesions on T1-WI (Gd+T1 lesions)

  7. Number of Patients by Reason for Stopping Siponimod Treatment

    Time frame: Months 6, 12, 18, 24

  8. Number of Patients With Siponimod-related Adverse Events

    Time frame: Months 6, 12, 18, through study follow-up, up to approximately 24 months

  9. Number of Patients With Siponimod-related Serious Adverse Events

    Time frame: Months 6, 12, 18, through study follow-up, up to approximately 24 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Retrospective, Multicenter, Non-interventional (Observational) Study With the Aim to Describe the Impact of Siponimod Treatment in a Real-world SPMS Population in Russia

Acronym: EMBOSSES

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

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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