NCT00380601已完成3 期
An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- Frequency of ACR 20％ improvement at the final visit
研究概览
简要总结
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
- •Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
- •Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study
排除标准
- •Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug
- •Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
- •Subjected to any of the following within 4 weeks before administration of the study drug:
- •Surgical treatment (operations,etc.).
- •Plasma exchange method
研究组 & 干预措施
1
Experimental
干预措施: MRA(Tocilizumab) (Drug)
结局指标
主要结局
Frequency of ACR 20％ improvement at the final visit
时间窗: throughout study
次要结局
- Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.(throughout study)
- Time course of DAS28 to the final visit.(throughout study)
- Time course of steroid sparing effect from first visit to final visit.(throughout study)
研究者
研究点 (10)
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