To study the effectiveness of tofacitinib as a first line therapy for treatment of moderate to severe ulcerative colitis and compare it with prednisolone.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- to compare the remission rate in both steroid and tofacitinib group
研究概览
简要总结
To study the effectiveness of tofacitinib as a first line therapy for treatment of moderate to severe ulcerative colitis and compare it with prednisolone. In recent clinical trials tofacitinib has been proven superior to placebo in moderate to severe UC for clinical remission and mucosal healing . The efficacy of Tofacitinib has not been directly compared against steroids. Alternative first line therapy to steroids for induction in patients with contraindication for steroids is also needed to be studied. So we planned this study to compare the efficacy of Tofacitinib against steroids for clinical remission and mucosal healing in patients having moderate to severe UC already on 5-ASA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •diagnosed cases of ulcerative colitis.
排除标准
- •ulcerative proctitis, severe commorbidity, c.
- •difficile infection, toxic mega colon, any coagulopathy or hypercoaguable condition, thrombosis, pregnancy.
结局指标
主要结局
to compare the remission rate in both steroid and tofacitinib group
时间窗: at 4th week, 8th week and 12th week
次要结局
- to compare the safety profile and adverse events of the individual drugs(3 months)