NCT01256736已完成3 期
Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2010年3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
- 89
- 试验地点
- 1
- 主要终点
- Safety results
研究概览
简要总结
The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
- •Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
- •Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
- •Willing to give written informed consent
排除标准
- •History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
- •ALT or AST > ULNⅹ2.5
- •Platelet count < 100ⅹ103/ μL
- •WBC < 3,000/mm3
- •Absolute neutrophil count < 1,000/mm3
- •Absolute lymphocyte count < 500/mm3
- •Total bilirubin > ULNⅹ2
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)
结局指标
主要结局
Safety results
时间窗: 48weeks
1. All AE/ADR during study 2. Physical examination including vital signs and ECG 3. Clinical laboratory results
次要结局
- Change of individual parameter in Rheumatoid factor(48 weeks)
- Change of individual parameter in ACR core set(48weeks)
- Change of individual parameter in DAS28(48weeks)
- Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy(48weeks)
- Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy(48weeks)
研究者
研究点 (1)
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