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Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance] (Enbrel-JIA)

2014年8月20日 更新者:Pfizer

Enbrel-JIA Use Results Survey [All-Case Surveillance]

This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.

  1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events
  2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

研究概览

详细说明

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

研究类型

观察性的

注册 (实际的)

113

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

      • Tokyo、日本
        • Yokohama City University School of

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

5年 至 16年 (孩子)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).

描述

Inclusion Criteria:

  • Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years).
  • Patients receiving Enbrel for JIA as diagnosed by a qualified physician.
  • Age 5 - 16 years

Exclusion Criteria:

  • Patients not administered ENBREL

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

  • 观测模型:仅案例
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Etanercept (genetical recombination)
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).
其他名称:
  • 恩布雷

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
Number of Participants With Treatment-Related Adverse Events of Etanercept
大体时间:24 weeks
Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.
24 weeks
Number of Participants With Serious Treatment-Related Adverse Events of Etanercept
大体时间:24 weeks
Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.
24 weeks
Number of Unlisted Treatment-Related Adverse Events of Etanercept
大体时间:24 weeks
Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.
24 weeks
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
大体时间:24 weeks
The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.
24 weeks

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Overall Improvement On Physician's Assessment.
大体时间:24 weeks
Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.
24 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

2009年7月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2010年6月9日

首先提交符合 QC 标准的

2010年6月15日

首次发布 (估计)

2010年6月16日

研究记录更新

最后更新发布 (估计)

2014年9月4日

上次提交的符合 QC 标准的更新

2014年8月20日

最后验证

2014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.

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