A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Compare EDSS change categories with changes in MusiQoL
研究概览
简要总结
The primary objective of the study is to determine the association between prospectively measured disability (Expanded Disability Status Scale [EDSS]) with quality of life (Multiple Sclerosis International Quality of Life Questionnaire [MusiQoL]) at 3-month intervals up to 1 year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The secondary objectives of this study are as follows: To evaluate the cumulative probability of sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function [FSMC]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 [MSISQ-19]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]) and neurocognitive function (Symbol Digit Modalities Test [SDMT]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to 6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse) and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe changes in work impairment (Work Productivity and Activity Impairment in MS [WPAI-MS]) at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe any change in the percentage of disability pension and occupation after 1 year of natalizumab treatment; To record the incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) throughout the study
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
- •Subjects that have a confirmed diagnosis of RRMS, as per the 2010 revised McDonald criteria
- •Subjects satisfying the therapeutic indication of natalizumab, as described in the local product label and confirmed by the Investigator. (Patients with previous treatment with natalizumab are also considered to be eligible only if the last natalizumab infusion was at least 1 year before the screening visit of this study)
- •Decision for a treatment with natalizumab has been made before screening
- •Patients with an EDSS score of 2.0-5.5 (both limits inclusive)
排除标准
- •Patients with a diagnosed co-existing brain pathology other than MS, which in the judgement of the investigator impacts the value of EDSS or QoL.
- •Pure spinal manifestation of demyelination
- •Diagnosis of primary or secondary progressive MS
- •Any change in concomitant medication known to affect cognition or bladder function
- •A history of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse, as assessed by the Investigator
- •NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.
研究组 & 干预措施
natalizumab
natalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland
干预措施: natalizumab (Drug)
结局指标
主要结局
Compare EDSS change categories with changes in MusiQoL
时间窗: At 1 year after initiating natalizumab treatment
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. The MusiQOL is a multidimensional Health Related Quality of Life (HRQoL) instrument that provides information based on the views and perceptions of the participants.
次要结局
- Cumulative probabilities of sustained improvement and progression in neurological disability(At 1 year after initiating natalizumab treatment)
- Compare EDSS change categories with EQ-5D(Up to 1 year after initiating natalizumab treatment)
- Compare FSMC score with EQ-5D(Up to 1 year after initiating natalizumab treatment)
- Comparison of BDI-FS with EQ-5D(Up to 1 year after initiating natalizumab treatment)
- Compare SDMT scores with EQ-5D(Up to 1 year after initiating natalizumab treatment)
- Rates of clinical relapses and relapses requiring steroid treatment(Up to 1 year after initiating natalizumab treatment)
- Compare clinical disease-free status (no sustained EDSS increase of 1.0 and no relapse) with MusiQoL(Up to 1 year after initiating natalizumab treatment)
- Compare MSISQ-19 scores with EQ-5D(Up to 1 year after initiating natalizumab treatment)
- Change in kind and percentage of occupation due to MS(At 1 year after initiating natalizumab treatment)
- Incidence and number of SAEs and SUSARs(Up to 1 year after initiating natalizumab treatment)
- Changes in the WPAI questionnaire(Up to 1 year after initiating natalizumab treatment)
- Change in the percentage of disability pension(At 1 year after initiating natalizumab treatment)