A 2-year Extension Study to Evaluate Long-term Effectiveness of Mavenclad® in Participants Who Have Completed Trial MS700568_0022 (MAGNIFY MS) (Magnify MS Extension)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 46
- 主要终点
- Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4
研究概览
简要总结
The primary purpose of this study was to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Participants of the MAGNIFY Multiple Sclerosis (MS) trial who received at least a single dose of cladribine tablets during the MAGNIFY MS trial and data on Magnetic resonance imaging (MRI) is available/acquired from at least parent study Month 18 or Month 24 visit and Expanded Disability Status Scale (EDSS) and relapse from parent study Month 24 visit
- •Capable of giving signed informed consent
排除标准
- •Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
- •Participation in other studies/trials
研究组 & 干预措施
Mavenclad®
干预措施: Mavenclad® (Drug)
结局指标
主要结局
Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4
时间窗: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study
The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5.
次要结局
- Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and at Year 4(At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study)
- Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Start of Study Medication During the Parent Study Until the End of Year 3 and Year 4(After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4)
- Percentage of Participants Remaining Three Parameter No Evidence of Disease Activity (NEDA-3) During Year 3 or 4 Among Those With NEDA-3 During Year 1 or 2(At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study)
- Time to First Disease Activity During Extension Study Period(From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years))
- Time to First Disease Activity During up to Parent and Extension Study Period (4 Years)(From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years))
- Time to First New or Enlarging T2 Lesion During Extension Study Period(From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years))
- Time to First Qualifying Relapse During Parent and Extension Study Period(From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years))
- Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Parent and Extension Study Period(From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years))
- Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Parent and Extension Study Period(From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years))
- Time to Recurrent Qualifying Relapse During Parent and Extension Study Period(From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years))
- Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period(From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years))
- Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Extension Study Period(From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years))
- Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Extension Study Period(From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years))
- Time to First Qualifying Relapse During Extension Study Period(From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years))
- Time to Recurrent Qualifying Relapse During Extension Study Period(From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years))
- Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Extension Study Period(From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years))