NCT00094341已完成4 期
An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 215
- 主要终点
- The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
研究概览
简要总结
The purpose of this study is to determine the preference of RA patients for the new Enbrel® (etanercept) pre-filled syringe in patients who are already taking Enbrel®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Have established RA diagnosis as determined by ACR criteria
- •Be current user of etanercept-lyophilized preparation for at least 4 consecutive weeks of etanercept dosing on either a once weekly or twice weekly regimen
- •Subject must be able to self inject
- •Give written informed consent
排除标准
- •Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
- •Subject of childbearing potential is pregnant (e.g., positive HCG test) or is breast-feeding
- •Elective surgery is planned during study period
- •Subjects allergic to latex
结局指标
主要结局
The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
次要结局
- Convenience of use and
- The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe as well as to the lyophilized preparation in the following categories:
- Confidence with the injection
- Hand discomfort during the injection
- Time involved with the injection
- Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.
- Ease of use
- To characterize the ability of patients to properly use by themselves either device independently and identify any sections of the instructions that were not clear, that may have led to loss of sterility to incomplete dosing
- Satisfaction with number of steps
- Nervousness with injection
研究者
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