A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 100 人开始时间: 2004年3月最近更新: 2007年12月14日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 100

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 4 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Inclusion in this study will be as per the approved indications in the package insert.
•Patients with moderately to severely active RA.
•Children with JRA who have had an inadequate response to one or more DMARDs.

排除标准

•Known hypersensitivity to etanercept or any of its components.
•Known significant concurrent medical disease, including:
•Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
•Cancer or history of cancer
•Active infection
•Sepsis or risk of sepsis
•Active tuberculosis or a past history of tuberculosis
•Pancytopenia
•Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
•Patients who are planning to undergo elective surgery during the study period.

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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