Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- DAS-28 CRP at 6 month
研究概览
简要总结
It is a randomized controlled study
详细描述
Randomization controlled study on Rheumatoid arthritis patients whos disease activity is high, controlled subjects will be given methotrexate and study subjects will get tofacitinib
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than 18 years
- •patients fulfill the ACR-EULAR classification criteria for RA 3.DAS-28 CRP more than 5.1
排除标准
- •systemic infection
- •hemoglobin less than 9 mg/dl
- •WBC <4000, neutrophil <1000, platelet <100000/mm
- •live vaccine within 3 months
- •GFR < 50 ml/min
- •ALT > 2 times ULN
研究组 & 干预措施
group A
group "A" is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs
干预措施: Methotrexate (Drug)
group B
group "B" will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months
干预措施: Tofacitinib (Drug)
结局指标
主要结局
DAS-28 CRP at 6 month
时间窗: 6 months
disease activity score in 28 joints has to measured at 6 months
次要结局
- SDAI at 6 months(6 months)
- HAQ-DI at 6 months(6 months)
研究者
Dr. Mohammad Mamun Khan
Resident, BSMMU
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh