NCT01765374已完成4 期
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis
University Hospital, Rouen7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- global score of power-doppler activity measured by ultrasonography on 12 joints
研究概览
简要总结
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •failure to at least one TNF-blocking agent
排除标准
- •pregnant or childbearing woman
- •Rituximab contraindication
- •woman unable to use contraceptive means
研究组 & 干预措施
rituximab
Experimental
Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
干预措施: ESAOTE MyLab60 (Device)
rituximab
Experimental
Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD)
干预措施: Rituximab (Drug)
结局指标
主要结局
global score of power-doppler activity measured by ultrasonography on 12 joints
时间窗: at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months)
Each time point will be assessed since the main objective of the study is to detect the time of sonographic relapse prior to clinical relapse
次要结局
未报告次要终点
研究者
研究点 (7)
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