A prospective randomised controlled trial of thiopurine methyltransferase (TPMT) genotyping in the management of patients, prior to commencement of azathioprine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30748308

Enrollment

1000

Registered

2005-06-29

Start date

2005-10-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Inflammatory bowel disease, arthritides and atopic dermatitis Not Applicable Inflammatory bowel disease, arthritides and atopic dermatitis

Interventions

Intervention: Genotyping for TPMT + standard care Control: Standard care with no TMPT genotyping

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients assessed as eligible for treatment with oral azathioprine in the management of selected conditions in gastroenterology, rheumatology or dermatology. Selected conditions in gastroenterology (ulcerative colitis, Crohn's disease, indeterminate colitis, autoimmune hepatitis), rheumatology (rheumatoid arthritis, systemic lupus erythematosus, vasculitis, Wegener's granulomatosis, dermatomyositis) or dermatology (atopic dermatitis, contact dermatitis, chronic actinic dermatitis).

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Neutropaenia (defined as a neutrophil count falling below 1 x 10^9/l) in the first four months of maintenance AZA treatment.	—

Secondary

Measure	Time frame
1. Reduction of AZA dose or stopping AZA because of intolerance in the first four months of maintenance AZA treatment. 2. Moderate neutropaenia (defined as a neutrophil count falling below 1.5 x 10^9/l) in the first four months of maintenance AZA treatment. 3. No reduction in drug efficacy in each of the three conditions (IBD, arthritides and atopic dermatitis) under study because of changes in the dose prescribed. This will be measured using standard tools to value improvement in clinical status for each condition, which will be collected on day 0 and month 4. 4. Patients who stop AZA therapy because of non-haematological toxicity within 4 months (e.g. nausea, hepatotoxicity, pancreatitis). This will be measured by recording all side effects attributed to AZA throughout the study period. 5. Health related quality of life status. A standardised generic health status measurement tool, the EQ-5D (EuroQoL), will be used to assess the impact on health related quality of life. The EQ-5D (EuroQoL) will be completed by all study participants on two occasions (day 0 and month 4).	—

Measure

Time frame

1. Reduction of AZA dose or stopping AZA because of intolerance in the first four months of maintenance AZA treatment. 2. Moderate neutropaenia (defined as a neutrophil count falling below 1.5 x 10^9/l) in the first four months of maintenance AZA treatment. 3. No reduction in drug efficacy in each of the three conditions (IBD, arthritides and atopic dermatitis) under study because of changes in the dose prescribed. This will be measured using standard tools to value improvement in clinical status for each condition, which will be collected on day 0 and month 4. 4. Patients who stop AZA therapy because of non-haematological toxicity within 4 months (e.g. nausea, hepatotoxicity, pancreatitis). This will be measured by recording all side effects attributed to AZA throughout the study period. 5. Health related quality of life status. A standardised generic health status measurement tool, the EQ-5D (EuroQoL), will be used to assess the impact on health related quality of life. The EQ-5D (EuroQoL) will be completed by all study participants on two occasions (day 0 and month 4).

—

Countries

United Kingdom

Outcome results

None listed

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