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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001503-37-DK

Enrollment

Registered

2013-05-06

Start date

2013-05-31

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease) MedDRA version: 14.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Imurel Pharmaceutical Form: Tablet INN or Proposed INN: azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: week 8, 12 and 24	—

Measure

Time frame

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. ;Timepoint(s) of evaluation of this end point: week 8, 12 and 24

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Secondary

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

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactMarianne Kiszka-Kanowitz

Hvidovre Hospital

marianne.kiszka-kanowitz@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026