Enbrel Special Use Result Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 684
- 试验地点
- 1
- 主要终点
- Number of Participants in Safety Analysis Population of Etanercept
研究概览
简要总结
The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following
- •Patients who are refractory to the treatment.
- •Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
- •Patients without a history of or concurrent malignant tumors.
排除标准
- 未提供
结局指标
主要结局
Number of Participants in Safety Analysis Population of Etanercept
时间窗: 3 years
Number of Participants With Treatment Related Adverse Events of Etanercept
时间窗: 3 years
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: 3 years
Serious treatment-related adverse events are defined as any events that lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.
Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept
时间窗: 3 years
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.
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
时间窗: 2 years
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
次要结局
- Modified Health Assessment Questionnaire (mHAQ) Score(2 years)
- European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)(2 years)
- Visual Analog Fatigue Scale (VAFS)(2 years)