NCT05811416进行中（未招募）不适用
Observational, Multicenter Study to Describe the Persistence in Relapsing Remitting Multiple Sclerosis Naive Patients With Low-moderate Activity Treated With Ozanimod (Zeposia®) in Clinical Practice in Spain
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation
研究概览
简要总结
The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.
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
- •Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start
- •Participant who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion, according to European Union (EU) Summary of Product Characteristics (SmPC) and/or Spanish therapeutic positioning report (TPR) recommendation and following routine clinical practice of the participating hospital
- •Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod
排除标准
- •Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study
- •Participant who has started ozanimod within a clinical trial
- •Note: Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation
时间窗: Up to 24 months
Percentage of participants on treatment with ozanimod at 24 months
时间窗: At month 24
次要结局
- Percentage of participants with ozanimod treatment discontinuation(Up to 24 months)
- Proportion of participants with a decrease SDMT score of ≥4 points(At month 3, 12 and 24)
- Proportion of participants with a stable SDMT score(At month 3, 12 and 24)
- Proportion of participants with change of ≥1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24(Baseline, Month 3, 12 and 24)
- Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24(Baseline, Month 12 and 24)
- Percentage of participants with ozanimod treatment at 3 and 12 months(At month 3 and month 12)
- Change from baseline in SDMT score at month 3, 12 and 24(Baseline, Month 3, 12 and 24)
- Number of Participants with at least one Adverse Event (AE)(Up to 24 months)
- Description of sociodemographic characteristics of participants(Baseline, up to 24 months)
- Annualized relapse rate at month 12 month and month 24(At month 12 and month 24)
- Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24(Baseline, Month 6, 12 and 24)
- Percentage of participants switching to treatment alternative(Up to 24 months)
- Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points(At month 3, 12 and 24)
- Change from baseline in EDSS score at Month 3, 12 and 24(Baseline, Month 3, 12 and 24)
- Number of Participants with AE that imply discontinuation of ozanimod(Up to 24 months)
- Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24(Baseline, Month 12 and 24)
- Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24(Baseline, Month 12 and 24)
- Description of clinical characteristics of participants(Baseline, up to 24 months)
研究者
研究点 (2)
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