Enbrel-JIA Use Results Survey [All-Case Surveillance]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Number of Unlisted Treatment-Related Adverse Events of Etanercept
研究概览
简要总结
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.
- Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events
- Secondary Factors affecting safety and to confirm the efficacy such as DAS28.
详细描述
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients not administered ENBREL
研究组 & 干预措施
Etanercept (genetical recombination)
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).
干预措施: Etanercept (genetical recombination) (Drug)
结局指标
主要结局
Number of Unlisted Treatment-Related Adverse Events of Etanercept
时间窗: 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.
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
时间窗: 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.
Number of Participants With Treatment-Related Adverse Events of Etanercept
时间窗: 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.
Number of Participants With Serious Treatment-Related Adverse Events of Etanercept
时间窗: 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.
次要结局
- Percentage of Participants With Overall Improvement On Physician's Assessment.(24 weeks)