The influence of adalimumab on thiopurine metabolism in Crohn's disease patients.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24966

Enrollment

Registered

2009-08-05

Start date

2008-01-03

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

interaction, adalimumab, azathioprine, 6-mercaptopurine, 6-thioguanine, thiopurines, 6-TGN, 6-MMPR

Interventions

None.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients, aged between 18 – 70 years; 2. Diagnosis of CD for at least 6 months (histological and endoscopically confirmed); 3. AZA, 6-MP or 6-TG use for at least 3 months; 4. Steady state AZA, 6-MP or 6-TG use, with an unchanged thiopurine regime for at least 6 weeks (in combination with Infliximab); 5. Normal liver and kidney function (ALAT / AP / creatinin 60ml/min.); 6. 5-ASA use for at least 8 weeks, and an unchanged dose regime for at least 6 weeks.

Exclusion criteria

Exclusion criteria: 1. Bone marrow suppression (platelets / leucocytes 1 x upper normal limit); 3. Anemia (hemoglobine < 6 mmoll); 4. Symptomatic stenosis of the ileum; 5. Small bowel surgery interfering significantly with resorptive area; 6. Known intolerance to Humira compounds; 7. Moderate-severe congestive failure (NYHA III/IV); 8. Current use of Humira; 9. Current use of methotrexate; 10. Start or dose regime change of 5-ASA compounds within the last 45 days; 11. Concomitant use of allopurinol, 5-ASA, mycofenolate, furosemide within the past 6 weeks; 12. Pregnancy, expected pregnancy or lactation within 6 months.

Design outcomes

Primary

Measure	Time frame
The influence of adalimumab therapy on the red blood cell levels of the active thiopurine metabolites (6-TGN and 6-MMPR) in Crohn's disease patients treated with stable azathioprine, 6-mercaptopurine or 6-thioguanine monotherapy.	—

Secondary

Measure	Time frame
1. The efficacy of concurrent treatment with the thiopurines azathioprine, 6-mercaptopurein or 6-thioguanine and adalimumab in Crohn's disease patients; 2. The safety during concurrent use of the thiopurines azathioprine, 6-mercaptopurine or 6-thioguanine and adalimumab in Crohn's disease patients.	—

Contacts

Public ContactD.R. Wong

Orbis Medical Centre Dr. H. van der Hoffplein 1

d.wong@orbisconcern.nl+31 88 459 7709

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)