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

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ClinicalTrials.gov Identifier: NCT02579733
Recruitment Status : Terminated (Not enough number of enrolling patient)
First Posted : October 20, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Celltrion
Information provided by (Responsible Party):
Eun Soo Kim, MD, PhD, Kyungpook National University

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.


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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Mucosal healing status [ Time Frame: one year ]
    Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579733


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 41944
Sponsors and Collaborators
Kyungpook National University
Celltrion
Investigators
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Principal Investigator: Eun Soo Kim, MD, PhD Kyungpook National University

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Responsible Party: Eun Soo Kim, MD, PhD, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02579733     History of Changes
Other Study ID Numbers: KMU-151016
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Azathioprine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents