Secondary Progressive Multiple SclerosisEMBOSSESNCT07168694
A Real-world Study About the Impact of Siponimod Treatment on Secondary Progressive Multiple Sclerosis Patients in Russia
An observational study of Secondary Progressive Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- How many people
- 606 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 26 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, non-interventional cohort study.
Who may be able to join
- Documented diagnosis of SPMS, with or without relapses.
- Treatment with siponimod for at least 6 months.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Keywords
- Siponimod, Treatment of multiple sclerosis, Real-world clinical data
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Siponimod Cohort | Adult patients with SPMS who were treated with siponimod. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics: Number of Patients by Age
Measured: Baseline
Demographics: Number of Patients by Gender
Measured: Baseline
Time Between MS Diagnosis and Treatment Initiation
Measured: Baseline
Time Between SPMS Diagnosis and Treatment Initiation
Measured: Baseline
Time Between First Symptoms and Treatment Initiation
Measured: Baseline
Number of Patients by Clinical Characteristic Category
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
Measured: Baseline
Number of Patients Categorized by Type of Treatment Received Before Initiation of Siponimod
Treatment categories included glucocorticosteroids, cytostatics, and disease-modifying treatments (DMTs).
Measured: Baseline
Number of Patients by DMT Received Before Initiation of Siponimod
Measured: Baseline
Duration of the Washout Period After Other DMTs and Before Initiation of Siponimod
Measured: Baseline
Number of Patients by Reason for Switching From Other DMTs to Siponimod
Measured: Baseline
Duration of Siponimod Therapy
Measured: Up to 2 years
Secondary outcomes (9)
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
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).
Measured: Baseline and Months 6, 12, 18, 24
Percentage of Patients With Confirmed Disability Progression Over 6 Months (6m-CDP) Based on the EDSS Score
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.
Measured: Months 6, 12, 18, 24
Number of Patients With MS Relapses
Measured: Baseline
Annualized Relapse Rate (ARR)
Measured: 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
Measured: 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
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)
Measured: Months 6, 12, 18, 24
Number of Patients by Reason for Stopping Siponimod Treatment
Measured: Months 6, 12, 18, 24
Number of Patients With Siponimod-related Adverse Events
Measured: Months 6, 12, 18, through study follow-up, up to approximately 24 months
Number of Patients With Siponimod-related Serious Adverse Events
Measured: Months 6, 12, 18, through study follow-up, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start16 Apr 2024
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168694
- Sponsor's protocol ID
- CBAF312ARU02
- Acronym
- EMBOSSES
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07168694
- Acronym / sponsor ID
- EMBOSSES / CBAF312ARU02
- Conditions
- Secondary Progressive Multiple Sclerosis
- Keywords
- Siponimod, Treatment of multiple sclerosis, Real-world clinical data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siponimod Cohort | – | –Adult patients with SPMS who were treated with siponimod. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, non-interventional cohort study.
Key inclusion criteria (2 listed)
- Documented diagnosis of SPMS, with or without relapses.
- Treatment with siponimod for at least 6 months.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographics: Number of Patients by Age
Time frame: Baseline
Demographics: Number of Patients by Gender
Time frame: Baseline
Time Between MS Diagnosis and Treatment Initiation
Time frame: Baseline
Time Between SPMS Diagnosis and Treatment Initiation
Time frame: Baseline
Time Between First Symptoms and Treatment Initiation
Time frame: 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
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).
Number of Patients by DMT Received Before Initiation of Siponimod
Time frame: Baseline
Duration of the Washout Period After Other DMTs and Before Initiation of Siponimod
Time frame: Baseline
Number of Patients by Reason for Switching From Other DMTs to Siponimod
Time frame: Baseline
Duration of Siponimod Therapy
Time frame: Up to 2 years
9 secondary outcomes
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Time frame: 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
Number of Patients With MS Relapses
Time frame: Baseline
Annualized Relapse Rate (ARR)
Time frame: 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
Number of Patients With MRI Signs of MS After Siponimod Treatment
Time frame: Months 6, 12, 18, 24
Number of Patients by Reason for Stopping Siponimod Treatment
Time frame: 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
Number of Patients With Siponimod-related Serious Adverse Events
Time frame: Months 6, 12, 18, through study follow-up, up to approximately 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Progressive Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics: Number of Patients by Age (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.