Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance (CHAMPIONS CONT)
Phase IV, Multi-center, Non-treatment, Observational, Registry Study to Determine Long Term Effects of AVONEX® Therapy on EDSS, MRI, QoL, and Cognition.
研究概览
地位
条件
详细说明
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)
2. 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
3. To determine early clinical and MRI predictors of disease progression.
Approximately 383 patients participated in CHAMPS, the original AVONEX® placebo trial, will be approached for study participation. The patient population will be divided into two cohorts.
Cohort 1: Patients that participated in CHAMPS and CHAMPIONS 10 will be approached for study participation at approximately twenty-four CHAMPIONS Continuation investigative sites.
Cohort 2: Patients that participated in CHAMPS will be located and approached for study participation. Patient that participated in CHAMPIONS 10 will not be excluded from Cohort 2. Efforts will be made to potentially locate patients through either the original CHAMPS investigative sites, through the Biogen Idec patient services database, and/or a third party (i.e., patient location service vendor) or some combination of the three. .
For both cohorts, public databases may be utilized for patient reported death.
研究类型
注册 (预期的)
联系人和位置
学习地点
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New York
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Buffalo、New York、美国、14203
- Research Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Approximately 383 patients participated in CHAMPS, the original AVONEX® placebo trial, will be approached for study participation. The patient population will be divided into two cohorts.
Cohort 1: Patients that participated in CHAMPS and CHAMPIONS 10 will be approached for study participation at approximately twenty-four CHAMPIONS Continuation investigative sites. Patients were diagnosed upon entry into CHAMPS with CIS demyelinating event with MRI lesions consistent with MS. Patients are eligible regardless of whether they have converted to Clinically Definite Multiple Sclerosis (CDMS) or not. Cohort 1 patients will have annual EDSS, self-report EDSS, medication review and relapse recalculation. SF-36 and SDMT assessments will be performed at years 1 and 5 during routine office visits. A MRI will be performed each patient's 15 year anniversary date. See Schedule of Assessments, section 12.
Cohort 2: Patients that participated in CHAMPS will be located and approached for s
描述
Inclusion Criteria:
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 10.
- 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).
Exclusion Criteria:
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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Cohort 1
Patients were diagnosed upon entry into CHAMPS with CIS demyelinating event with MRI lesions consistent with MS.
Patients are eligible regardless of whether they have converted to Clinically Definite Multiple Sclerosis (CDMS) or not.
Cohort 1 patients will have annual EDSS, self-report EDSS, medication review and relapse recalculation.
SF-36 and SDMT assessments will be performed at years 1 and 5 during routine office visits.
A MRI will be performed each patient's 15 year anniversary date.
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Cohort 2
Patients were diagnosed upon entry into CHAMPS with CIS demyelinating event with MRI lesions consistent with MS.
Patients are eligible regardless of whether they have converted to Clinically Definite Multiple Sclerosis (CDMS) or not.
Patients will be waiving written informed consent and asked to provide concomitant medication, self-reported EDSS, and SF-36 only.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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EDSS
大体时间:yearly
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yearly
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MRI
大体时间:last visit, 15 year anniversary
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last visit, 15 year anniversary
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次要结果测量
结果测量 |
大体时间 |
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Quality of Life
大体时间:year 1 & 5
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year 1 & 5
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Symbol Digit Modality Test
大体时间:year 1 & 5
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year 1 & 5
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 004-09-AVX
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