Phase IV, Multi-center, Non-treatment, Observational, Registry Study to Determine Long Term Effects of AVONEX® Therapy on EDSS, MRI, QoL, and Cognition.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 383
- 试验地点
- 1
- 主要终点
- MRI
研究概览
简要总结
Phase IV, multi-center, non-treatment, observational, registry study to determine long term effects of AVONEX® therapy on EDSS, MRI, QoL, and cognition.
详细描述
The primary objective of this study is to determine the impact of long term AVONEX® treatment on physical status, measured by expanded disability scale score (EDSS), of patients with Multiple Sclerosis (MS) after their first clinical event (clinically isolated syndrome) and Magnetic Resonance Imaging (MRI) consistent with MS.
Secondary objectives are to determine the impact of long term therapy with AVONEX® on the following:
a) MRI parameters- new or enlarging T2 lesions, T2 lesion volume, T1 lesion volume, brain parenchymal fraction (BPF) b) Quality of Life (QoL): Heath Status Questionnaire (SF-36) c) Symbol Digit Modality Test (SDMT)
-
To determine the long term impact of therapy on the following in patients treated at the onset of clinically isolated event (CIS)
-
EDSS
-
MRI parameters
-
SF-36
-
SDMT
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible to be screened for this study if all of the following criteria are met:
- •All patients must have been originally enrolled in CHAMPS, regardless of randomization arm. Only Cohort 1 patients must have been enrolled in CHAMPIONS
- •Willing and able to provide informed consent (Cohort 1), waiver of informed consent (Cohort 2), or reported patient death through public database search.
- •Ability to read and write English (patient reported assessment tools are in English only).
排除标准
- •Candidates will be excluded from study screening if any of the following exclusion criteria exist:
- •Patients not participating in the original CHAMPS study.
- •Alternative diagnosis to MS discovered.
- •Patient unwilling or unable to provide informed consent (Cohort 1) or waiver of informed consent (Cohort 2), as applicable.
- •Any other reasons that, in the opinion of the Investigator (Cohort 1) or Patient Coordination Center (Cohort 2), the patient is determined to be unsuitable for enrollment into this study.
结局指标
主要结局
MRI
时间窗: last visit, 15 year anniversary
EDSS
时间窗: yearly
次要结局
- Quality of Life(year 1 & 5)
- Symbol Digit Modality Test(year 1 & 5)