Retrospective, Multicenter, Non-interventional (Observational) Study With the Aim to Describe the Impact of Siponimod Treatment in a Real-world SPMS Population in Russia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- Demographics: Number of Patients by Age
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Demographics: Number of Patients by Age
时间窗: Baseline
Time Between First Symptoms and Treatment Initiation
时间窗: Baseline
Demographics: Number of Patients by Gender
时间窗: Baseline
Time Between MS Diagnosis and Treatment Initiation
时间窗: Baseline
Time Between SPMS Diagnosis and Treatment Initiation
时间窗: Baseline
Number of Patients by Clinical Characteristic Category
时间窗: 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
时间窗: Baseline
Treatment categories included glucocorticosteroids, cytostatics, and disease-modifying treatments (DMTs).
Number of Patients by DMT Received Before Initiation of Siponimod
时间窗: Baseline
Duration of the Washout Period After Other DMTs and Before Initiation of Siponimod
时间窗: Baseline
Number of Patients by Reason for Switching From Other DMTs to Siponimod
时间窗: Baseline
Duration of Siponimod Therapy
时间窗: Up to 2 years
次要结局
- 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)
- Number of Patients With MRI Signs of MS After Siponimod Treatment(Months 6, 12, 18, 24)
- Number of Patients by Reason for Stopping Siponimod Treatment(Months 6, 12, 18, 24)
- Number of Patients With Siponimod-related Adverse Events(Months 6, 12, 18, through study follow-up, up to approximately 24 months)
- Number of Patients With Siponimod-related Serious Adverse Events(Months 6, 12, 18, through study follow-up, up to approximately 24 months)