A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Percentage of Successful Self-injections to Total Non-missed Injections
研究概览
简要总结
The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept (Enbrel®).
详细描述
Study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a 4-week screening period and a 5-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on history.
- •Subject is willing to self-inject per investigator judgement at screening.
- •Subject has no known history of tuberculosis.
排除标准
- •Latex allergy.
- •Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first study dose of etanercept.
- •Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.
- •Other criteria may apply.
研究组 & 干预措施
Etanercept / Autoinjector A
Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
干预措施: Etanercept / Autoinjector A (Drug)
结局指标
主要结局
Percentage of Successful Self-injections to Total Non-missed Injections
时间窗: Week 1, Week 2, Week 3, Week 4 and Week 5
The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.
次要结局
- Percentage of Autoinjector A System Failures(Week 1, Week 2, Week 3, Week 4 and Week 5)
- Percentage of Errors in Each Step of the Self-injection Process(Week 1, Week 2, Week 3, Week 4 and Week 5)