NCT02579733

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

October 16, 2015

Last Update Submit

August 12, 2019

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Mucosal healing status

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

    one year

Study Arms (2)

Azathioprine

ACTIVE COMPARATOR

Azathioprine (1.5mg/kg) po for 1 year

Drug: Azathioprine

Sugar pill

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AzathioprineDRUG
Azathioprine
PlaceboDRUG
Sugar pill

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with azathioprine or biologics therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Related Publications (1)

  • Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.

    PMID: 40013523DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Azathioprine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Eun Soo Kim, MD, PhD

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

February 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

KR(1)