CTRI/2012/01/002371已完成4 期
A clinical outcomes study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) in comparison withetanercept (ETA) on the rate of cardiovascular events inPatients with moderate to severe rheumatoid arthritis (RA)
F HoffmannLa Roche Ltd0 个研究点目标入组 2,800 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult patients, greater or equal 50 years of age
- •Patients with moderate to severe rheumatoid arthritis greater or equal 6 months duration
- •Inadequate response to at least one non-biologic disease-modifying antirheumatic drug (DMARD)
- •History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low HDL cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis
排除标准
- •Major surgery within 8 weeks prior to screening or planned major surgery within 1 year of study start
- •Rheumatic autoimmune disease other than rheumatoid arthritis
- •History of, or current, inflammatory joint disease other than rheumatoid arthritis
- •Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (Myocardial infarction, revascularization, stroke, transient ischaemic attack, or acute coronary syndrome)
- •History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations
- •Active current infection or history of recurrent bacterial infection
- •Previous treatment with tocilizumab or etanercept
研究者
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