Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
2018年8月1日 更新者：Amgen
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
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®).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
77
阶段
- 第三阶段
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
-
-
Alabama
-
Huntsville、Alabama、美国、35801
- Research Site
-
-
Arizona
-
Peoria、Arizona、美国、85381
- Research Site
-
Phoenix、Arizona、美国、85037
- Research Site
-
-
California
-
Santa Maria、California、美国、93454-6945
- Research Site
-
Upland、California、美国、91786
- Research Site
-
-
Colorado
-
Denver、Colorado、美国、80230
- Research Site
-
-
Florida
-
Sarasota、Florida、美国、34239
- Research Site
-
Tampa、Florida、美国、33614
- Research Site
-
-
Kentucky
-
Paducah、Kentucky、美国、42003
- Research Site
-
-
Nebraska
-
Lincoln、Nebraska、美国、68516
- Research Site
-
-
New York
-
Orchard Park、New York、美国、14127
- Research Site
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73103
- Research Site
-
-
Pennsylvania
-
Duncansville、Pennsylvania、美国、16635
- Research Site
-
-
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:
- 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.
Exclusion Criteria:
- 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.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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).
|
Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).
其他名称：
|
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 |
|---|---|---|
|
Percentage of Successful Self-injections to Total Non-missed Injections
大体时间：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.
|
Week 1, Week 2, Week 3, Week 4 and Week 5
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Autoinjector A System Failures
大体时间：Week 1, Week 2, Week 3, Week 4 and Week 5
|
The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers.
System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.
|
Week 1, Week 2, Week 3, Week 4 and Week 5
|
|
Percentage of Errors in Each Step of the Self-injection Process
大体时间：Week 1, Week 2, Week 3, Week 4 and Week 5
|
For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported.
If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not.
• Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).
|
Week 1, Week 2, Week 3, Week 4 and Week 5
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events
大体时间：9 weeks
|
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study.
The definition includes worsening of a pre-existing medical condition.
A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
An adverse device effect is any adverse event related to the use of a medical device.
Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.
|
9 weeks
|
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11日
初级完成 (实际的)
2013年12月18日
研究完成 (实际的)
2013年12月30日
研究注册日期
首次提交
2013年5月17日
首先提交符合 QC 标准的
2013年7月16日
首次发布 (估计)
2013年7月17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.