IBD patients, inadequately responding (lack of response and/or intolerance) to standard thiopurine therapy
Conditions
Interventions
None listed
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: 1. IBD diagnosis, according to current ECCO guidelines for at least 3 months (UC is characterised by diffuse mucosal inflammation limited to the colon; CD is characterised by patchy, transmural inflammation which may affect any part of GI tract). 2. Currently using 6-TG and willing to switch to Thiosix formulation. 3. The subject must have signed the ICF voluntarily before data is entered in the study database, after having been informed about the purpose of the study and by whom and in what way his/her medical and treatment data will be used.
Exclusion criteria
Exclusion criteria: 1. Patients younger than 18 years 2. Breastfeeding women 3. Previously demonstrated clinically significant allergy or hypersensitivity to the study drug or to any of the excipients of the medication. 4. Patients using 6-TG in another formulation than Thiosix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Monitor the incidence of NRH in IBD patients using 6-thioguanine as Thiosix | — |
Secondary
| Measure | Time frame |
|---|---|
| • Examine the safety of treatment with 6-thioguanine, as Thiosix, for 1 year or longer in IBD patients • Follow-up on long-term efficacy of 6-TG (Thiosix) treatment in IBD patients | — |
Contacts
Public ContactFemke Schepers
Teva Nederland
Outcome results
None listed