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

September 4, 2025 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
606

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

Description

Inclusion criteria:

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

Exclusion criteria:

None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Siponimod Cohort
Adult patients with SPMS who were treated with siponimod.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographics: Number of Patients by Age
Time Frame: Baseline
Baseline
Demographics: Number of Patients by Gender
Time Frame: Baseline
Baseline
Time Between MS Diagnosis and Treatment Initiation
Time Frame: Baseline
Baseline
Time Between SPMS Diagnosis and Treatment Initiation
Time Frame: Baseline
Baseline
Time Between First Symptoms and Treatment Initiation
Time Frame: Baseline
Baseline
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
Baseline
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).
Baseline
Number of Patients by DMT Received Before Initiation of Siponimod
Time Frame: Baseline
Baseline
Duration of the Washout Period After Other DMTs and Before Initiation of Siponimod
Time Frame: Baseline
Baseline
Number of Patients by Reason for Switching From Other DMTs to Siponimod
Time Frame: Baseline
Baseline
Duration of Siponimod Therapy
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and Months 6, 12, 18, 24
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.
Months 6, 12, 18, 24
Number of Patients With MS Relapses
Time Frame: Baseline
Baseline
Annualized Relapse Rate (ARR)
Time Frame: 1 and 2 years before siponimod initiation and 6, 12, 18, and 24 months after siponimod treatment
1 and 2 years before siponimod initiation and 6, 12, 18, and 24 months after siponimod treatment
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
1 year before siponimod initiation and 6, 12, 18, and 24 months after siponimod treatment
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)
Months 6, 12, 18, 24
Number of Patients by Reason for Stopping Siponimod Treatment
Time Frame: Months 6, 12, 18, 24
Months 6, 12, 18, 24
Number of Patients With Siponimod-related Adverse Events
Time Frame: Months 6, 12, 18, through study follow-up, up to approximately 24 months
Months 6, 12, 18, through study follow-up, up to approximately 24 months
Number of Patients With Siponimod-related Serious Adverse Events
Time Frame: Months 6, 12, 18, through study follow-up, up to approximately 24 months
Months 6, 12, 18, through study follow-up, up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBAF312ARU02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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