临床试验/NCT00078793

NCT00078793已完成不适用

Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis

Amgen0 个研究点目标入组 600 人开始时间: 2000年6月最近更新: 2013年5月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Amgen
入组人数: 600
主要终点: Adverse event rates and severity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate long-term safety of etanercept with or without other DMARDs in children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or without other DMARDs.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 2 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Methotrexate group

Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept.

干预措施: Enbrel® (Drug)

结局指标

主要结局

Adverse event rates and severity

时间窗: 36 months of observation

次要结局

Growth data and Tanner scores(36 months of observation)

研究者

发起方

Amgen

申办方类型

Industry

责任方

Sponsor

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Unknown

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