Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis (ACE)

Kyungpook National University

Status and phase: Terminated; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Azathioprine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02579733

KMU-151016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Azathioprine

Active Comparator group

Description:

Azathioprine (1.5mg/kg) po for 1 year

Treatment:

Drug: Azathioprine

Sugar pill

Placebo Comparator group

Description:

Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year

Treatment:

Drug: Placebo