NCT05658601已完成不适用
SWITCH - ITA A Multicentre, Single Country, Prospective Non Interventional Observational Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod, in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated According to Clinical Practice.
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年7月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Mode of switching treatment
研究概览
简要总结
The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with RRMS according to 2017 revised McDonald criteria
- •Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
- •Patient with a MRI performed within three months before the enrollment
- •Patient eligible to ozanimod according to SmPC
排除标准
- •Patients with clinical forms of MS other than RRMS
- •Patients unable to participate for various reasons
- •Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
- •Contraindications to ozanimod according to SmPC
- •Other protocol-defined Inclusion/Exclusion Criteria apply.
结局指标
主要结局
Mode of switching treatment
时间窗: At baseline
Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments
Reason for switching treatment
时间窗: At baseline
Reason for switching the previous treatment: Lack of efficacy, Poor safety/tolerability, Difficulty in administration, Poor compliance, Patient's request, or other reasons
次要结局
- MRI(At baseline, week 12, and week 24)
- Lymphocyte sub populations(At baseline, week 12, and week 24)
- Incidence of Adverse Events (AEs)(Continuous (Up to 42 months))
- Incidence of Serious Adverse Events (SAEs)(Continuous (Up to 42 months))
- Expanded Disability Status Score (EDSS)(At baseline, week 12, and week 24)
- TSQM(At baseline and week 24)
研究者
研究点 (1)
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