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

NCT07168694 | Completed

• 1 other identifier: CBAF312ARU02
• Study Type: observational
• Target: 606
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (11)

• Demographics: Number of Patients by Age

  Baseline

• Demographics: Number of Patients by Gender

  Baseline

• Time Between MS Diagnosis and Treatment Initiation

  Baseline

• Time Between SPMS Diagnosis and Treatment Initiation

  Baseline

• Time Between First Symptoms and Treatment Initiation

  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

  Baseline

• Number of Patients Categorized by Type of Treatment Received Before Initiation of Siponimod

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

  Baseline

• Number of Patients by DMT Received Before Initiation of Siponimod

  Baseline

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

  Baseline

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

  Baseline

• Duration of Siponimod Therapy

  Up to 2 years

Secondary Outcomes (9)

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

  Baseline and Months 6, 12, 18, 24

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

  Months 6, 12, 18, 24

• Number of Patients With MS Relapses

  Baseline

• Annualized Relapse Rate (ARR)

  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

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

Study Arms (1)

Siponimod Cohort

Adult patients with SPMS who were treated with siponimod.

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, non-interventional cohort study.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Novartis Pharmaceuticals: 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 4, 2025
• First Posted: September 11, 2025
• Study Start: April 16, 2024
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)