EUCTR2010-020065-24-ES进行中（未招募）1 期
A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult patients, >/=50 years of age
- •- Patients with moderate to severe rheumatoid arthritis >/=6 months duration
- •- Inadequate response to at least one non-biologic disease-modifying antirheumatic drug (DMARD)
- •- Presence of one or more additional Coronary Heart Disease (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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 800
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 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)
研究者
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