NCT01613079已完成2 期
Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- ACR50
研究概览
简要总结
Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years with informed consent
- •Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks
- •Swollen joint (SJC)≥3 and tender joint count(TJC)≥5
- •ESR >28 mm/hr or C-reactive protein > 20 mg/L
排除标准
- •Pregnant, lactating or further fertility requirements
- •Previous treated with methotrexate or biologic DMARD.
- •Active or chronic infection, including HIV, HCV, HBV, tuberculosis
- •Patient with cancer
研究组 & 干预措施
Methotrexate
Placebo Comparator
Patients were treated with methotrexate alone.
干预措施: Methotrexate (Drug)
T2
Experimental
Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
干预措施: Tripterygium wilfordii Hook F (Drug)
MTX+T2
Experimental
The patients were treated with methotrexate and T2.
干预措施: Tripterygium wilfordii Hook F (Drug)
MTX+T2
Experimental
The patients were treated with methotrexate and T2.
干预措施: Methotrexate (Drug)
结局指标
主要结局
ACR50
时间窗: 24 weeks.
The proportion of patients achieving ACR50.
次要结局
- DAS28(24 weeks)
- ACR20/70(24 weeks)
- Radiology outcome(24 weeks)
研究者
Xuan Zhang
Professor
Peking Union Medical College Hospital
研究点 (1)
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