Swiss Study of the Impact of Mayzent (Siponimod) on Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change of expanded disability status scale (EDSS)
研究概览
简要总结
This study is a national, prospective, multicenter, non-interventional (observational) study with the aim to describe the impact of Siponimod treatment in a real-world SPMS population in Switzerland who are treated with Siponimod as per Swiss label.
详细描述
Primary data will be collected during an observational period of three years of Siponimod treatment. Additionally, medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of Siponimod treatment effects on an individual basis. It is planned to include an optional blood draw for a later biomarker analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed informed consent
- •Adult patients with a documented diagnosis of SPMS with inflammatory disease activity who are going to be treated with Siponimod under routine medical care and in accordance with the Swiss label
- •Patient willing and able to complete the questionnaires
排除标准
- •Patients treated outside of the approved Swiss label for Siponimod
- •Prior treatment or already ongoing treatment with Siponimod
- •Use of investigational drugs during the study, OR within 3 months before enrollment, OR within 5 half-lives of investigational drug before enrollment, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- •Subjects who are not able to provide consent due to incapable judgement
结局指标
主要结局
Change of expanded disability status scale (EDSS)
时间窗: Baseline, month 36
The EDSS score is a widely used tool for determining the degree of disability in MS at any point in time. The EDSS value is generated based on overall impression and individual scores of the following functional systems: cognition, mood, fatigue, vision, brain stem, upper extremities, lower extremities, bladder and bowel function, sexuality. This results in a scale from 0 (healthy) to 10 (death from MS)
次要结局
- Proportion of patients with six month confirmed disease progression by symbol digit modalities test (SDMT)(Up to 36 months)
- Treatment effect of Siponimod on walking speed as measured by the timed 25 foot walk test (T25FWT)(Baseline, up to 36 months)
- Proportion of patients with six month confirmed disability progression (CDP) by expanded disability status scale (EDSS)(month 36)
- Treatment effect of Siponimod on quality of life based on EQ-5D(Baseline, month 36)
- Treatment effect of Siponimod on fatigue measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)(Baseline, month 36)
- Treatment effect of Siponimod on fatigue measured by Beck's depression inventory (BDI)(Baseline, month 36)
- Treatment effect of Siponimod on fatigue measured by Epworth sleepiness scale (ESS) questionnaire(Baseline, month 36)