Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease

Phase 1

• Conditions: Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease); MedDRA version: 14.1Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-001503-37-DK
• Lead Sponsor: Marianne Kiszka-Kanowitz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-06
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

•All subjects must give written informed consent.
•Male or female subjects, between the ages of 18 and 80.
•Subjects with Ulcerative colitis and Crohn’s disease that according to the treatment guidelines in the department is recommended treatment with AZA.
•UC and CD diagnosed by known criteria.
•Normal TPMT, phenotype =14

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Kidney failure, creatinine >120 mmol/L
•Elevated liverenzymes (ALAT)
•Infection with clostridium dificile
•Participation in other medication trials

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to compare clinical remission rate and rate of adverse drug effect in IBD patients with normal TPMT treated with conventional AZA therapy compared to combination therapy with ALLO and low dose AZA. ;Secondary Objective: not applicable;Primary end point(s): To compare the proportion of patients with IBD in clinical remission according to Mayo or Harvey-Bradshaw index (HBi) after treatment with AZA or AZA and ALLO at week 8, 12 and 24.<br><br>;Timepoint(s) of evaluation of this end point: week 8, 12 and 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •To compare adverse effects to the treatment after 8, 12 and 24 weeks in the two groups.<br>•To compare calprotectin levels after 4, 8, 12 and 24 weeks in the two groups.<br>•To compare quality of life after 8, 12 and 24 weeks in the two groups.<br>•To compare the proportion of patients with clinical response at week 8, 12 and 24<br>;Timepoint(s) of evaluation of this end point: week 8, 12 and 24.