Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis
试验速览
- 阶段
- 2 期
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- remission induction at 30 weeks
研究概览
简要总结
Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.
This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11
详细描述
Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.
This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11 patients with active takayasu's arteritis
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
- 是
入选标准
- •active takayasu's arteritis
排除标准
- •active Tuberculosis
- •Liver function abnormality
- •heart failure ( New York Heart Association III - IV)
- •patients were not consented
研究组 & 干预措施
experimental group
anti Tumor necrosis factor treatment group : treatment with remicade 5mg/kg as scheduled (0, 2, 6, 14, 22, 30, 38, 46, 54weeks).
evaluation of response at 30weeks by PET CT, acute phase reactants, symptom
No placebo group
干预措施: remicade (anti tumor necrosis factor inhibitor) (Drug)
结局指标
主要结局
remission induction at 30 weeks
时间窗: 30 weeks
次要结局
未报告次要终点