A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel disease

Phase 1

Active, not recruiting

Conditions: Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-004112-35-SE

Lead Sponsor: SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

1.Age 18-80 years at the time of inclusion, weight between 50 and 100 kg.

2.Willingness to comply with all trial procedures and being available for the duration of the trial.

3.Clinical and histological verified IBD eligible for treatment with thiopurines due to steroid dependence (failure to taper steroid or starting a second course of systemic steroids within one year) or due to the need for thiopurines for other reasons (disease phenotype, i.e post-surgery decision).

4.A written informed consent to participate in the study is signed before any study-related procedures are performed.

5.A normal TPMT activity measurement (>8.9 U/ml RBC) or normal TPMT genotype (*1/*1).

6.Naïve to thiopurine treatment

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Biologic treatment (anti-TNF, vedoluzimab etc) within the last three months prior the study

2.Concurrent participation in another interventional therapy study.

3.Females who are pregnant or breastfeeding

4.Females of childbearing age and potential who are not willing or capable to use acceptable methods of contraception (oral contraceptives, condoms, diaphragms, intrauterine devices) during the entire study and for up to 3 months after the end-of-study evaluation.
5.Male patients who do not use acceptable barrier methods of contraception (condoms) during the entire course of the study and up to 3 months after the end-of-study evaluation.

6.Inability to follow the treatment protocol (as judged by the investigator)

7.Current treatment with Allopurinol.

8.Patients with gout that needs medical treatment.

9.Estimated GFR < 50 ml/ml

10.Persistent alanine aminotransferase U/L (ALT) above upper limit of the normal range.