Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®).
研究概览
简要总结
This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a
详细描述
The study was an open-label, multi-center, international post-marketing study (phase 4). Eligible patients were interferon naïve patients suffering from relapsing MS. The duration of a subject's participation in the study was up to a maximum 26 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing Remitting Multiple Sclerosis
- •Interferon naïve
- •Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics:
- •Subject has had relapsing MS for > 1 year
- •Subject has had experienced 2 exacerbations in the last 2 years
- •Subject had an EDSS [5] score of < 5.5
- •Subject was ambulant
排除标准
- •Diagnosis of MS defined as progressive
- •History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta
- •History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin
- •History of seizures within the 3 months prior to starting this study
- •History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the study
- •History of intolerance to interferons
- •Previous use of interferon beta
- •Female subjects who were pregnant or breast-feeding
- •For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception
研究组 & 干预措施
1
patients received Avonex IM injections and be evaluated for quality of life criteria
干预措施: Interferon beta-1a (Drug)
结局指标
主要结局
The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®).
时间窗: screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24
次要结局
- Reproducibility of Quality of Life scales per language version(months 18 and 24)
- Reliability of the Quality of Life scales per language version(months 18 and 24)
- EDSS score throughout the study(screening, Day -1, Months 12 and 24)