Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
2018年8月1日 更新者：Amgen
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
217
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Victoria、British Columbia、加拿大、V8V 3P9
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、加拿大、A1C 5B8
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Ontario
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Barrie、Ontario、加拿大、L4M 7G1
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Burlington、Ontario、加拿大、L7R 1E2
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Courtice、Ontario、加拿大、L1E 3C3
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Hamilton、Ontario、加拿大、L8N 1Y2
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Mississauga、Ontario、加拿大、L5M 2V8
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Oakville、Ontario、加拿大、L6J 7W5
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Peterborough、Ontario、加拿大、K9J 1Z2
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Alabama
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Huntsville、Alabama、美国、35801
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Tuscaloosa、Alabama、美国、35406
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Arizona
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Glendale、Arizona、美国、85304
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Scottsdale、Arizona、美国、85258
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Arkansas
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Hot Springs、Arkansas、美国、71913
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California
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San Diego、California、美国、92108
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San Ramon、California、美国、94583
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Santa Maria、California、美国、93454-6945
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Tustin、California、美国、92780
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Colorado
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Denver、Colorado、美国、80230
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Florida
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Dunedin、Florida、美国、34698
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Tampa、Florida、美国、33614
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Kansas
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Overland Park、Kansas、美国、66215
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Kentucky
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Louisville、Kentucky、美国、40217
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Maryland
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Frederick、Maryland、美国、21702
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Michigan
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Lansing、Michigan、美国、48910
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Nebraska
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Lincoln、Nebraska、美国、68516
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New York
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Orchard Park、New York、美国、14127
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North Dakota
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Bismarck、North Dakota、美国、58502
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Ohio
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Dayton、Ohio、美国、45417
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Oklahoma
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Oklahoma City、Oklahoma、美国、73103
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Pennsylvania
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Duncansville、Pennsylvania、美国、16635
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Wyomissing、Pennsylvania、美国、19610
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South Carolina
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Charleston、South Carolina、美国、29414
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Tennessee
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Hixson、Tennessee、美国、37343
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Texas
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Austin、Texas、美国、78731
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Dallas、Texas、美国、75231
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West Virginia
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Clarksburg、West Virginia、美国、26301
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria: 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. -
Exclusion Criteria: 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Autoinjector A
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
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Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.
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实验性的：Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
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Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
大体时间：Week 8
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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?"
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Week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Needle Apprehension at Week 4
大体时间：Baseline and Week 4
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Participants' needle apprehension was assessed using the Subject's Perception of Self-Injecting Questionnaire.
Participants answered the question "Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector" using a scale from 1 (extremely nervous) to 5 (not at all nervous).
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Baseline and Week 4
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Ease of Use
大体时间：At the end of each treatment period; Week 4 and Week 8
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Ease of use was assessed based on responses to questions 1 to 6 of the Subject's Experience with the Autoinjector Questionnaire: 1.
How easy was it to learn how to use the autoinjector?
2. How easy was it for you to press the button to start the injection?
3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection?
5. How easy was it for you to inject yourself using the autoinjector?
6.
How easy was it to follow the progress of the injection?
Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy).
The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.
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At the end of each treatment period; Week 4 and Week 8
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Certainty of Completing the Injection With the Autoinjector
大体时间：At the end of each treatment period; Week 4 and Week 8
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Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject's Experience with the Autoinjector Questionnaire: "How certain were you that you knew when the injection was finished?"
Participants answered on a scale from 1 (Not at all) to 5 (Extremely).
The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Convenience
大体时间：At the end of each treatment period; Week 4 and Week 8
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Convenience was assessed based on responses to Question 8 of the Subject's Experience with the Autoinjector Questionnaire: "How convenient was the autoinjector to use?" Participants answered on a scale from 1 (Not at all) to 5 (Very much).
The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Discomfort
大体时间：At the end of each treatment period; Week 4 and Week 8
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Discomfort was assessed based on responses to Question 9 of the Subject's Experience with the Autoinjector Questionnaire: "How much discomfort did you experience when giving yourself the medicine using the autoinjector?"
Participants answered on a scale from 1 (None) to 5 (Very much).
The percentage of participants who scored a 1 (None) or 2 (A little) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Satisfaction
大体时间：At the end of each treatment period; Week 4 and Week 8
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Satisfaction was assessed based on responses to questions 11 and 12 of the Subject's Experience with the Autoinjector Questionnaire.
Question 11: "How dependable (durable, sturdy, reliable) did you feel the autoinjector device was?" answered on a scale from 1 (Not at all) to 5 (Very much).
Question 12: "Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept?" answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend).
The percentage of participants who scored either a 4 or 5 on each question is reported.
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At the end of each treatment period; Week 4 and Week 8
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Pain Associated With Use of the Autoinjector
大体时间：At the end of each treatment period; Week 4 and Week 8
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Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject's Experience with the Autoinjector Questionnaire: "Using this scale, select the circle that best describes how much it hurt when giving yourself an injection."
Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst).
The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported.
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At the end of each treatment period; Week 4 and Week 8
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Strength of Preference for Autoinjector A and Autoinjector B
大体时间：Week 8
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Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8.
After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).
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Week 8
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年6月5日
初级完成 (实际的)
2014年3月4日
研究完成 (实际的)
2014年3月4日
研究注册日期
首次提交
2013年6月10日
首先提交符合 QC 标准的
2013年6月10日
首次发布 (估计)
2013年6月12日
研究记录更新
最后更新发布 (实际的)
2018年9月4日
上次提交的符合 QC 标准的更新
2018年8月1日
最后验证
2018年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.