Ulcerative Colitis
Conditions
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.
Interventions
DRUGAzathioprine
DRUGPlacebo
Sponsors
Celltrion
Kyungpook National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients with azathioprine or biologics therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal healing status | one year | Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score. |
Countries
South Korea
Outcome results
None listed