Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Abbott0 个研究点目标入组 200 人开始时间: 2003年12月最近更新: 2007年10月3日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Abbott
入组人数: 200
主要终点: QOL

研究概览研究设计入排标准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

The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
•Subject has a diagnosis of rheumatoid arthritis as defined by the 1987 ACR criteria
•Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

排除标准

•Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
•Female subject who is pregnant or breast-feeding or considering becoming pregnant
•Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months

结局指标

主要结局

QOL

时间窗: 12 months

次要结局

Patient reported outcomes
Clinical response indicators
Safety parameters

研究者

发起方

Abbott

申办方类型

Industry

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