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

• Sponsor: Kyungpook National University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02579733
• Collaborator: Celltrion (Industry)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Azathioprine; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Azathioprine Azathioprine (1.5mg/kg) po for 1 year	Drug: Azathioprine
Placebo Comparator: Sugar pill Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Mucosal healing status [one year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National University Hospital	Daegu		Korea, Republic of	41944

Sponsors and Collaborators

• Kyungpook National University Hospital
• Celltrion

Investigators

• Principal Investigator: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eun Soo Kim, MD, PhD, Professor, Kyungpook National University Hospital
• ClinicalTrials.gov Identifier: NCT02579733
• Other Study ID Numbers: KMU-151016
• First Posted: Oct 20, 2015
• Last Update Posted: Aug 14, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Azathioprine

Study Results

No Results Posted as of Aug 14, 2019