临床试验/NCT00132418

NCT00132418已完成4 期

Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders

Amgen0 个研究点目标入组 564 人开始时间: 2000年4月最近更新: 2011年1月21日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Amgen
入组人数: 564
主要终点: Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics

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

The objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.

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 (Participant, Investigator)

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

•Active RA - Documented comorbid condition (diabetes mellitus requiring insulin or oral hypoglycemic agents; chronic pulmonary disease; history of pneumonia in the last year; or recurrent bronchitis, sinusitis or urinary tract infection) - Able to self-inject study drug

排除标准

•Previous use of anti-tumor necrosis factor (TNF) monoclonal antibody - Receipt of anti-CD4 or diphtheria interleukin-2 fusion protein within the previous 6 months with subsequent abnormal absolute T cell count - Receipt of intra-articular corticosteroids within 2 weeks before screening - Receipt of cyclosporine, thalidomide or azathioprine within 4 weeks before screening - Significant concurrent medical diseases (serious infection; open cutaneous ulcers; current antibiotic treatment; myocardial infarction [MI] within 12 months of screening; angina pectoris; uncontrolled hypertension; cancer; or HIV positive)

研究组 & 干预措施

Placebo

Placebo Comparator

placebo

干预措施: Placebo (Drug)

Enbrel

Experimental

Enbrel

干预措施: Enbrel (Drug)

结局指标

主要结局

Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics

时间窗: 16 weeks

次要结局

Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events(16 weeks)

研究者

发起方

Amgen

申办方类型

Industry

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