NCT00915577已完成3 期
An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 74
- 主要终点
- The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe
研究概览
简要总结
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be using liquid AVONEX® to treat MS. In addition, the subject must be on liquid AVONEX® for 12 weeks prior to the Screening Visit.
- •Must have a BMI of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at Screening.
- •Must be able to physically demonstrate use of the device and be able to self-administer all injections.
- •Must be English speaking.
- •Must be able to understand and comply with the protocol.
排除标准
- •Abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (WBC) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (ALT) aspartate transaminase (AST), prothrombin time (PT).
- •Known sensitivity to dry natural rubber.
- •Treatment with other agents to treat MS symptoms or underlying disease as specified in the protocol.
- •History of severe allergic or anaphylactic reactions.
- •History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
- •Serious local infection
- •Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
研究组 & 干预措施
1st Injection
Experimental
Manual injection with pre-filled syringe.
干预措施: Interferon beta-1a (Drug)
Single-use autoinjector
Experimental
Single-use autoinjector with Avonex pre-filled syringe
干预措施: Single-use autoinjector (Device)
结局指标
主要结局
The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe
时间窗: The study duration is 8 Weeks
次要结局
未报告次要终点
研究者
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