An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
研究概览
简要总结
The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.
详细描述
Candidates for treatment are those who in the determination of the investigator's standard of care and the caring physician's intent are to initiate treatment with etanercept. Participants must be naïve to etanercept and naïve to other autoinjector pens or prefilled syringes and be able to self-inject. The study will consist of a 30 day screening period, and 2 treatment periods of 4 weeks duration each (one treatment period using Autoinjector A and the other using Autoinjector B). At the end of the study, participants may continue treatment with commercially available etanercept at the physician's discretion.
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
- •Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous biologics for RA. - Willing to self-inject per investigator judgement at screening and capable of self-injection using the autoinjector A or B as documented at baseline by the investigator. - Able to read and write in English. -
排除标准
- •Latex allergy. - Subject has an active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first 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
Autoinjector A
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
干预措施: Etanercept via Autoinjector A (Drug)
Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
干预措施: Etanercept via Autoinjector B (Drug)
结局指标
主要结局
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
时间窗: Week 8
Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question "Which autoinjector do you prefer overall?"
次要结局
- Change From Baseline in Needle Apprehension at Week 4(Baseline and Week 4)
- Ease of Use(At the end of each treatment period; Week 4 and Week 8)
- Certainty of Completing the Injection With the Autoinjector(At the end of each treatment period; Week 4 and Week 8)
- Convenience(At the end of each treatment period; Week 4 and Week 8)
- Discomfort(At the end of each treatment period; Week 4 and Week 8)
- Satisfaction(At the end of each treatment period; Week 4 and Week 8)
- Pain Associated With Use of the Autoinjector(At the end of each treatment period; Week 4 and Week 8)
- Strength of Preference for Autoinjector A and Autoinjector B(Week 8)