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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Azathioprine
Placebo
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kyungpook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Azathioprine

Sugar pill

Arm Description

Azathioprine (1.5mg/kg) po for 1 year

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

Outcomes

Primary Outcome Measures

Mucosal healing status
Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2015
Last Updated
August 12, 2019
Sponsor
Kyungpook National University Hospital
Collaborators
Celltrion
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1. Study Identification

Unique Protocol Identification Number
NCT02579733
Brief Title
Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
Acronym
ACE
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Not enough number of enrolling patient
Study Start Date
February 1, 2016 (undefined)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
Collaborators
Celltrion

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azathioprine
Arm Type
Active Comparator
Arm Description
Azathioprine (1.5mg/kg) po for 1 year
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mucosal healing status
Description
Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Soo Kim, MD, PhD
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of

12. IPD Sharing Statement

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

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