Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 8
- 主要终点
- Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets
研究概览
简要总结
The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Physician diagnosis of HDA-RRMS as defined by clinical or radiological features
- •Treatment initiation with cladribine tablet monotherapy on or after 22 August 2017 and at least 3 years before enrolment
- •Completion of Year 1 treatment of cladribine tablets (Week 1 and Week 2 treatment, per recommended dose in Year 1: 1.75 milligrams per kilogram [mg/kg] body weight, cumulatively)
排除标准
- •Received cladribine tablet treatment within an interventional clinical trial during the study period
- •Received treatment with any investigational therapy for RRMS in the 6 months prior to cladribine tablet treatment initiation
结局指标
主要结局
Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets
时间窗: 1 Year prior to date of Cladribine tablet initiation
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in the year prior to the date of Cladribine tablet initiation.
Annualized Relapse Rate in the Year One After Treatment Initiation With Cladribine Tablets
时间窗: Year 1 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 1 after treatment initiation with Cladribine tablets.
Annualized Relapse Rate in the Year 2 After Treatment Initiation With Cladribine Tablets
时间窗: Year 2 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 2 after treatment initiation with Cladribine tablets.
Annualized Relapse Rate in the Year 3 After Treatment Initiation With Cladribine Tablets
时间窗: Year 3 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 3 after treatment initiation with Cladribine tablets.
Annualized Relapse Rate in the Year 4 After Treatment Initiation With Cladribine Tablets
时间窗: Year 4 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 4 after treatment initiation with Cladribine tablets.
Annualized Relapse Rate in the Year 5 After Treatment Initiation With Cladribine Tablets
时间窗: Year 5 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 5 after treatment initiation with Cladribine tablets.
次要结局
- Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment(Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets until relapse or death)
- Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion(From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2))
- Time From Cladribine Tablet Initiation to First Relapse(up to maximum 5 years after treatment initiation with Cladribine tablets)
- Number of Participants Who Discontinued Cladribine Tablets(From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2))
- Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2(At Treatment Initiation and Start of Treatment Year 2)
- Number of Participants With Disability Progression Confirmed Over 6 Months, Assessed by Expanded Disease Severity Scale (EDSS) at 2 Years After Cladribine Tablet Treatment Initiation(At 2 years after treatment initiation with Cladribine tablets)
- Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies(At 2 years after treatment initiation with Cladribine tablets)