De novo combination allopurinol-thiopurine vs standard thiopurine in inflammatory bowel disease (IBD) patients escalating to immunomodulators: a randomized controlled trial

Phase 3

Recruiting

• Conditions: Inflammatory Bowel Disease; Oral and Gastrointestinal - Inflammatory bowel disease; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12613001347752
• Lead Sponsor: Eastern Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-09
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

•Age 18 - 80 years
•Confirmed UC or CD diagnosis
•Evidence for active disease as determined by baseline faecal calprotectin > or = 150µg/g and/or SCCAI > or = 4 (for UC) or HBI > or = 5 (for CD) at baseline screening visit
•Require commencement of thiopurine therapy according to the patient’s treating physician
•Stable doses of other IBD medications (standardized prednisolone weaning schedule only, maintenance biologics only, aminosalicylates at same dose only) for three months prior to enrolment

Exclusion Criteria

•Unable to understand adequate English
•Unable to give informed consent
•Pregnancy or breastfeeding, or planning to become pregnant and breast feed during the study period
•Medical comorbidities including concurrent sepsis, advanced chronic liver disease, malignancy, haematological disorders causing one or more cytopenias, or any other medical condition that the investigators feel would preclude study entry
•Previous serious adverse reaction to a thiopurine or allopurinol
•Low thiopurine methyltransferase (TPMT) activity at baseline visit (<5 U/ml) or TPMT homozygous genotype (TPMTL/ TPMTL) if previously tested
•Unable to tolerate two weeks of either azathioprine 50mg or mercaptopurine 25mg (or half these doses if TPMT intermediate metaboliser or TPMT genotype 1*/3*)
•Stage 4 or worse chronic kidney disease (an eGFR <30mL/min/1.73m2)

Study & Design

• Study Type: Interventional
• Study Design: Not specified