A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 60
- 主要终点
- Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48
研究概览
简要总结
The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.
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
- •Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT)
- •Received at least a single dose of cladribine tablets in the CLARIFY MS study
- •Completed the Final Study Visit (M24) of the CLARIFY MS study
- •Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
排除标准
- •Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
- •Participation in other studies.
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 or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48
时间窗: Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)
The SDMT is a test of information processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a "key", showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110 where higher scores indicated improvement and lower scores indicated worsening.
次要结局
- Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years(Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665))
- Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years(Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665))