BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 261
- 试验地点
- 120
- 主要终点
- Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
研究概览
简要总结
The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.
This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study
排除标准
- •Subjects who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the subject's ability to understand the purpose of the study
- •Suspected clinical instability or unpredictability of the clinical course during the study(e.g., due to previous surgery or acute stroke)
研究组 & 干预措施
Experimental arm 15 years ago
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
干预措施: Brain MRI (Other)
Experimental arm 15 years ago
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
干预措施: Blood sampling (Other)
Placebo arm, offered treatment at MS diagnosis or at Month 24
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
干预措施: Brain MRI (Other)
Placebo arm, offered treatment at MS diagnosis or at Month 24
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
干预措施: Blood sampling (Other)
结局指标
主要结局
Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
时间窗: Over 15 years since the subject´s first clinical event
Disease course since start of BENEFIT as assessed at the time of BENEFIT 15
时间窗: Over 15 years since the subject's first clinical event
Time to first relapse
时间窗: Over 15 years since the subject´s first clinical event
Time to recurrent relapse
时间窗: Over 15 years since the subject´s first clinical event
Annualized relapse rate
时间窗: Over 15 years since the subject´s first clinical event
Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)
时间窗: Over 15 years since the subject´s first clinical event
Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)
时间窗: Over 15 years since the subject´s first clinical event
Time to use of ambulatory device
时间窗: Over 15 years since the subject´s first clinical event
Time to dependence on ambulatory device
时间窗: Over 15 years since the subject´s first clinical event
Employment status (Standardized questions)
时间窗: At one single visit, 15 years after the subject's first clinical event
The current employment will be recorded
Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)
时间窗: Over 15 years since the subject´s first clinical event
Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination
时间窗: 15 years after the subject´s first clinical event
Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)
时间窗: Over 15 years since the subject´s first clinical event
Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)
时间窗: Over 15 years since the subject´s first clinical event
MSFC: Multiple Sclerosis Functional Composite
Resource use assessment questions: Adaptions (past 6 months)
时间窗: At one single visit, 15 years after the subject's first clinical event
Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
时间窗: Over 15 years since the subject´s first clinical event
Time to use of wheelchair
时间窗: Over 15 years since the subject´s first clinical event
Resource use assessment questions: Additional ambulatory services during relapse
时间窗: At one single visit, 15 years after the subject's first clinical event
Multiple sclerosis impact on employment
时间窗: At one single visit, 15 years after the subject's first clinical event
Resource use assessment questions: Help from family/regular ambulatory services
时间窗: At one single visit, 15 years after the subject's first clinical event
次要结局
- European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score(Over 15 years since the subject´s first clinical event)
- Symbol Digit Modalities Test score (SDMT score)(At one single visit, 15 years after the subject's first clinical event)
- European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score(Over 15 years since the subject's first clinical event)
- Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)(At one single visit, 15 years after the subject's first clinical event)
- Relation of mental processing speed and MRI parameters(At one single visit, 15 years after the subject's first clinical event)
- Center of Epidemiological Studies for Depression (CES-D) score(At one single visit, 15 years after the subject's first clinical event)
- Time to first disease-modifying therapies (DMT) other than IFNB-1b(Over 15 years since the subject´s first clinical event)
- Functional Assessment of Multiple Sclerosis (FAMS score)(Over 15 years since the subject´s first clinical event)
- Fatigue Scale for Motor and Cognitive Functions (FSMC score)(At one single visit, 15 years after the subject's first clinical event)
- Time to second line therapy(Over 15 years since the subject´s first clinical event)