CTRI/2025/11/097363尚未招募2 期
A randomised controlled trial to compare the efficacy of Tofacitinib versus Tofacitinib and Budesonide MMX for induction of clinical remission in moderate to severe Ulcerative Colitis
Postgraduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical remission
研究概览
简要总结
This is an open label, parallel group, randomised controlled trial to be conducted in India’s tertiary care centre, PGIMER, Chandigarh. This study evaluates the combined effectiveness of tofacitinib and budesonide MMX for the treatment of moderate to severe ulcerative colitis and compare it with tofacitinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged more than 18 years with moderate to severe ulcerative colitis, diagnosed by clinical, endoscopic and histologic criteria.
排除标准
- •Patients in remission,
- •Patients with ASUC defined as per the Truelove and Witt’s Criteria
- •Patients with disease limited to 15 cm from anal verge (proctitis only)
- •Patients with toxic megacolon
- •Patients with any serious infection, defined as any infection that requires hospitalization or change in the treatment plan
- •Patients with Indeterminate colitis or Crohn’s disease
- •Patients with prior history of exposure to tofacitinib
- •Patients with prior use of steroids in the last 3 months
- •Lactating and pregnant females
- •Patients with suspected or proven malignancy
- •Patients with dyslipidemia precluding the use of tofacitinib
- •Patients with severe comorbidities
- •Patients with diagnosed case of liver cirrhosis 14.
结局指标
主要结局
Clinical remission
时间窗: 12 weeks
次要结局
- 1) Mucosal healing(2) Clinical response)
研究者
Dr Sayan Mazumder
Postgraduate Institute of Medical Education and Research
研究点 (1)
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