Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Mucosal healing status
研究概览
简要总结
The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.
详细描述
The sample size was calculated based on the previous study showing the difference of mucosal healing rate between azathioprine (58%) and 5-aminosalicylate (21%). With a two-tailed test of α = 0.05 and 1 - ß = 0.8, 52 patients were required.
The placebo drug which is identical to azathioprine will be provided by Celltrion drug company.
Differences in the categorical variables between the groups are examined with χ2 or the Fisher exact test. For comparisons of continuous variables, a Student t test is used.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative colitis patients with moderate to severe activity who achieved a clinical remission by the first course of corticosteroids
- •Newly diagnosed or without steroid use during last 1 year
- •Endoscopic Mayo subscore >0
排除标准
- •Patients with azathioprine or biologics therapy
研究组 & 干预措施
Azathioprine
Azathioprine (1.5mg/kg) po for 1 year
干预措施: Azathioprine (Drug)
Sugar pill
Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year
干预措施: Placebo (Drug)
结局指标
主要结局
Mucosal healing status
时间窗: one year
Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score.
次要结局
未报告次要终点
研究者
Eun Soo Kim, MD, PhD
Professor
Kyungpook National University Hospital