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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Azathioprine

Azathioprine (1.5mg/kg) po for 1 year

Group Type ACTIVE_COMPARATOR

Azathioprine

Intervention Type DRUG

Sugar pill

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Azathioprine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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