An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 408
- 主要终点
- The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.
研究概览
简要总结
To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.
- •Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-
- •Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-
- •have not been diagnosed with any other disease that accounts for their neurologic symptoms.
排除标准
- •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 seizure within the 3 months prior to enrollment.
- •Abnormal laboratory results at the screening visit:
- •History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.
- •Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
研究组 & 干预措施
1
Patients previously enrolled in BIogen Idec study C95-812.
干预措施: Interferon beta-1a (Avonex) (Drug)
2
Patients previously enrolled in Biogen Idec study C96-823.
干预措施: Interferon beta-1a (Avonex) (Drug)
3
Patients previously enrolled in Biogen Idec study C97-830.
干预措施: Interferon beta-1a (Avonex) (Drug)
结局指标
主要结局
The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.
时间窗: The study duration is 7 months
次要结局
- To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.(The study duration is 7 months)