NCT01211834已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Proportion of patients with ACR20 responses
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •adult patients, >= 18 years of age
- •Active RA of > 6monts duration
- •Received permitted DMARDs each at a stable dose for at least 8 weeks
排除标准
- •Rheumatic autoimmune disease other than RA
- •Significant systemic involvement secondary to RA
- •ALT or AST > ULNⅹ1.5
- •Platelet count < 100,000/mm3
- •Hemoglobin < 8.5 g/dL
- •White blood cells < 3,000/mm3
- •Absolute neutrophil count < 2,000/mm3
- •Absolute lymphocyte count < 500/mm3
研究组 & 干预措施
Tocilizumab 8mg/kg+DMARDs
Experimental
干预措施: tocilizumab (Drug)
Tocilizumab 8mg/kg+DMARDs
Experimental
干预措施: DMARDs (Drug)
Placebo+DMARDs
Placebo Comparator
干预措施: Placebo (Drug)
Placebo+DMARDs
Placebo Comparator
干预措施: DMARDs (Drug)
结局指标
主要结局
Proportion of patients with ACR20 responses
时间窗: 24weeks
Proportion of patients with ACR20 responses at post therapy
次要结局
- Proportion of patients with ACR50 and ACR70 responses at post therapy(24weeks)
- Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin(24weeks)
研究者
研究点 (1)
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