Prospective, Non-interventional, Multicenter Study to Evaluate QoL and Influence of Cognitive Status on QoL in Patients With RRMS During 2 Years Treatment With RNF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
This is a prospective, non-interventional, multicenter study to evaluate quality of life (QoL) and influence of cognitive status on QoL in subjects with relapsing-remitting multiple sclerosis (RRMS) during two years of treatment with Rebif New Formulation (RNF).
详细描述
Multiple sclerosis (MS) is an acquired demyelinating disease of unclear etiology, occurring mainly in adults. Multiple sclerosis occurs in 30-100 people per 100 000. Usually the disease attacks young adults aged between 20 and 40 years. The peak of this occurrence is in the population of 30-35 year olds.
The main feature of the disease is multifocal (disseminated) injury of the central nervous system. The injury causes various neurological symptoms and signs that go on and off (relapsing-remitting form) or progress steadily, and with time cause irreversible damage of the nervous system and permanent disability. In neuropsychological studies, 40-65% of MS subjects show cognitive impairment with prominent involvement of memory, sustained attention and information processing speed. Multiple sclerosis subjects with different disease courses have different cognitive profiles.
Cognitive dysfunction can have a dramatic impact on a subject's QoL, influencing the fulfillment in work and social life, independently from physical disability. The methodology of cognitive status assessment in MS is based on established sets of tests, which could be conduced by qualified neurophysiologists. There is a need of simple test that could be quickly conducted by every physician, providing information of cognitive status/ or one of its parameters (attention/concentration). That kind of information could be immediately used by the physician during the visit to adjust the way of taking history or giving advices to subjects.
During the last 10 years there's been an enormous progress in the MS treatment. New drugs appeared that proved to diminish clinical activity of the disease and slow its progress. Early treatment with disease modifying therapies may reduce cognitive impairment or slow down the progression of cognitive deficits.
The scope of this study is to evaluate the cognitive status (attention/concentration) and the influence of cognitive impairment on QoL in subjects with RRMS during two years of treatment with RNF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged above 18 years
- •Subjects with clinically diagnosed RRMS which is characterised by two or more acute exacerbations in the previous two years
- •Subjects who has never been treated with Rebif (previous treatment with other DMDs will not be regarded as an exclusion criterion)
- •Written consent to cooperation made by the environmental nurse who takes care about subject in hospital as well as in his home
- •Score of 21 or more points, according to National Heath Found Patient inclusion criteria for the 2 years program of MS treatment with interferon beta
排除标准
- •Exclusion criteria conform with Rebif's registered contraindications, described in an Sm PC approved by Ministry of Health.
- •Interferon beta-1a is contraindicated during pregnancy
- •Interferon beta-1a is contraindicated in subjects with confirmed hypersensitivity to natural or recombined interferon beta, or to any of the adjuvant substances
- •Interferon beta-1a is contraindicated in subjects with severe depression and/or suicidal thoughts
结局指标
主要结局
Quality of Life
时间窗: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months)
To evaluate the QoL by assessing the changes in MusiQoL Questionaire scores
次要结局
- Assessment of Cognitive Status(Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months))
- Assessment of number of relapses(Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months))
- Influence of cognitive impairment on QoL in subjects with RRMS(Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months))
- Assessment of results of Evoked Potentials (visual, auditory, somatosensory/ if they are routinely done)(Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months))
- Assessment of Expanded Disability Status Scale(Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months))
- Assessment of Magnetic Resonance Imaging results(Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months))