A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- To investigate the MS related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months.
研究概览
简要总结
The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months. The secondary objectives are: To investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol), sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking at different times points after initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking are measured at 6 and 12 months. To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to document any changes in fatigue related medication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tysabri prescribed according to national guidelines but not yet started treatment
- •Signed informed consent form
- •FSMC sum score above > 43 at baseline (mild fatigue)
排除标准
- •FSMC sum score below 43 at baseline
- •History of treatment with Tysabri
- •EDSS > 6 at baseline
- •Amphetamine as medication
- •Major depression
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
结局指标
主要结局
To investigate the MS related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months.
时间窗: 0 month and 12 months
A fatigue scale for motor and cognitive functions (FSMC) has been developed and validated by Penner et al. FSMC differentiates between motor and cognitive fatigue and is less susceptible to confounding by depression. Thus, FSMC is more specific in measuring MS-related fatigue.
次要结局
- Changes in fatigue after initiation of Tysabri treatment(3 months, 6 months, 9 months)
- Change in capacity for work (capacity for work questionnaire (CWQ)) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression(6 months, 12 months)
- Change in amount of walking (step counter) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- Change in Sleepiness (Epworth sleepiness scale (ESS)) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- Change in cognitive impairment (the paced auditory serial addition test (PASAT) and symbol digit modalities test (SDMT)) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- Change in depression (Center for epidemiologic studies depression scale (CES-D)) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- Change in Physical activity induced exhaustion (Borg scale CR10 (BS-CR10)) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- Change in health-related-quality of life (HRQ0L) (short form-12 questions (SF-12)) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- Change in speed of walking (6MWT) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- Change in status of MS disease progression (expanded disability status scale (EDSS)) at different points after initiation of Tysabri treatment(0, 6 months, 12 months)
- To document any changes in fatigue related medication(12 months)