Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis

Amgen0 个研究点开始时间: 2001年5月1日最近更新: 2009年11月26日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Amgen

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

The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

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

•diagnosed with rheumatoid arthritis for at least 6 months
•must be taking methotrexate * must not take DMARDS other than methotrexate during the study
•must not have had previous treatment with and protein-based TNF-alpha inhibitor (eg. etanercept, infliximab, PEG sTNF-RI, or D2E7)
•must not have had previous treatment with anakinra
•subjects must meet tender and swollen joint requirements at screening, have morning stiffness, and/or have elevated acute phase reactants

排除标准

未提供

研究者

发起方

Amgen

申办方类型

Industry

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