Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT02579733
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- Patients with azathioprine or biologics therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugar pill Placebo Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year Azathioprine Azathioprine Azathioprine (1.5mg/kg) po for 1 year
- Primary Outcome Measures
Name Time Method Mucosal healing status one year Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of