Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 26
- 主要终点
- Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years
研究概览
简要总结
The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.
详细描述
The CHAMPS study determined that immediate initiation of interferon beta 1a therapy (AVONEX) immediately following a first clinical demyelinating event in high risk patients (i.e. those with at least 2 asymptomatic white matter lesions on cranial MR imaging > 3 mm in diameter or ovoid) delayed the development of clinical definite Multiple Sclerosis (CDMS)(as defined by a second, clinically verifiable attack involving another part of the central nervous system) over 2 years of observation and significantly decreased the development of new or enlarging white matter lesions on MRI over 18 months (see reference). The current study is a long term extension of a cohort of CHAMPS study site and participants. The three main aims of the study are as follows:
- To determine the long term neurological outcome in patients treated with interferon beta 1a (AVONEX) from onset of a first clinical demyelinating event
- To determine if immediate initiation of AVONEX therapy (the CHAMPS Avonex treatment group) confers long term benefits compared to delayed initiation of therapy (the CHAMPS placebo group) on the rate of development of CDMS, annualized relapse rates, the development of permanent disability and MR measures of disease activity and progression.
- To determine predictors of long term disease activity and disability in patients following a first clinical demyelinating event
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open label study: The outcome committee determined the primary outcome event (the development of Clinically definite MS) without knowledge of original treatment assignment and the central MRI reading center was not aware of original treatment assignments
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
- •Previous participation in CHAMPS study
- •Participation in a study site willing to participate in the CHAMPIONS10 extension study
- •Willingness to enroll in the CHAMPIONS 10 extension
- •Willingness to sign informed consent
排除标准
- •Discovery of an alternative neurological disorder other than MS as a cause of initial neurological symptoms
- •A severe systemic disease with likely mortality within 3 years
研究组 & 干预措施
Immediate Treatment Group
Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals
干预措施: interferon beta 1a 30 ug IM once weekly (Drug)
Delayed Treatment Group
Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation
干预措施: interferon beta 1a 30 ug IM once weekly (Drug)
结局指标
主要结局
Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years
时间窗: 10 years
Percent cumulative probability of developing CDMS over 10 years . CDMS was defined as the development of new visual or neurological symptoms discrete from the patients initial event with objective findings on examination.
次要结局
- Annualized Relapse Rate(10 years)
- Number of Participants With an EDSS > 3.5 at Study Completion(10 years)
- The Number of New or Enlarging MRI T2 Lesions at 10 Years(10 years)
研究者
R. Philip Kinkel
Principal Investigator
Beth Israel Deaconess Medical Center