NCT00195416已完成不适用
A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 526 人开始时间: 2005年6月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 526
研究概览
简要总结
To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.
- Unknown adverse reactions, especially serious adverse reactions
- Change of the incidences of adverse reactions under the routine drug uses
- Factors that may affect the safety of the drug
- Factors that may affect the effectiveness of the drug
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy
排除标准
- •Patients with known hypersensitivity to Enbrel or any component of the product
- •Patients with sepsis or risk of sepsis
- •Patients with active infections including chronic or localized infections such as tuberculosis.
研究者
相似试验
已完成
不适用
A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsARheumatoid ArthritisNCT00195403Pfizer1,014
已完成
不适用
Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)ArthritisRheumatoidNCT01230177Pfizer3
已完成
不适用
Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and ChildrenRheumatoid ArthritisNCT00484809Wyeth is now a wholly owned subsidiary of Pfizer100
已完成
不适用
Special Drug Use Investigation for ALLERMIST (Long Term)RhinitisNCT01420822GlaxoSmithKline500
已完成
不适用
Arnuity® Ellipta® Drug Use InvestigationAsthmaNCT03184480GlaxoSmithKline336