NCT05376579已完成不适用
Impact of Mayzent (Siponimod) on Active Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study in Italy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 25
- 主要终点
- Proportion of patients with six-month CDP during 36 months of treatment
研究概览
简要总结
This is an observational, multicenter, single-arm, prospective study conducted in Italy
详细描述
Primary data will be collected over a period of three years. Medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of the effects of siponimod treatment on an individual basis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent: patient must provide written informed consent before any study assessment is performed.
- •Male/female participants aged between 18 and
- •Documented diagnosis of active SPMS.
- •Siponimod treatment as routine medical care: patients newly treated with siponimod (starting not more than 7 days before baseline visit), for whom the decision to start treatment has already been taken independently of study inclusion based on clinical practice and according to SmPC and AIFA criteria, and who successfully qualified for treatment with siponimod (i.e. passed the screening procedure mandated by the SmPC and Risk Management Plan (RMP) for this treatment, including genotyping for CYP2C9 to determine CYP2C9 metaboliser status).
排除标准
- •Patients treated outside the approved siponimod label or with any controindication indicated in the SmPC.
- •Pregnant or lactating women.
- •Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the investigator's judgement.
- •Current participation in an interventional trial.
- •Treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).
结局指标
主要结局
Proportion of patients with six-month CDP during 36 months of treatment
时间窗: 36 months
Confirmed disability progression (CDP) is defined as a ≥1.0-point worsening of Expanded Disability Status Scale (EDSS) score from ≤5.0 baseline or a 0.5-point worsening from \>5.0 baseline for at least 6 months OR a ≥4.0-point confirmed cognitive worsening (CCW) from baseline of Symbol Digit Modalities Test (SDMT) for at least 6 months.
次要结局
- Annualized relapse rate (ARR)(Month 12, month 24 and month 36)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- Symbol Digit Modality test (SDMT)(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- Number of new/newly enlarging T2 [neT2] and Gd+T1 lesions(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- Expanded Disability Status Scale scores(Month 12, month 24 and month 36)
- Expanded Disability Status Scale trend(Month 12, month 24 and month 36)
- UK Neurological Disability Scale (UKNDS)(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- MS activity status (MS-AS) - number of relapse(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- MS activity status (MS-AS) - Number of patients with presence of symptoms(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- Exposure adjusted proportion of patients with adverse event (AE) or serious adverse event (SAE) per 100 subject-years(Up to 36 months)
- Discontinuation rates due to AE or other reasons(Up to 36 months)
- Proportion of patients with No Evidence of Disease Activity (NEDA)-3(Month 12, month 24 and month 36)
- Fatigue Scale for Motor and Cognitive Functions (FSMC)(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- T25-foot-walk(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- EQ-5D: EuroQol five-dimensional(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- Clinical Global Impression (CGI)(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- 9-Hole peg test(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- TSQM-9: Treatment Satisfaction Questionnaire for Medication(Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36)
- Proportion of patient who required FDO when starting siponimod and the reason why(Baseline)
研究者
研究点 (25)
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