A 6-thioguanine (6-TG) registry that explores the effectiveness and safety of 6-TG in the treatment of inflammatory bowel disease (IBD) in 6-TG naïve patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21729

Enrollment

104

Registered

2019-02-25

Start date

2015-07-02

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

IBD patients, inadequately responding (lack of response and/or intolerance) to standard thiopurine therapy, naïve on 6-TG treatment.

Interventions

None listed

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. Eligible for starting with 6-TG (formulated as Thiosix) treatment according to the treating physician. 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 5. Patients who have not used AZA or 6-MP prior to 6-TG treatment 6. Patients using 6-TG in combination with TNF-alpha inhibitors, ustekinumab or vedolizumab

Design outcomes

Primary

Measure	Time frame
Maintenance of remission (HBI < 5 or SCCAI = 2) without surgery throughout at least 12 months allowing 1 time additional corticosteroid use for a maximum duration of 3 months.	—

Secondary

Measure	Time frame
The proportion of patients in whom remission (HBI < 5 or SCCAI = 2) is maintained with one course of corticosteroid for a maximum of 3 months without surgery throughout at least 6 months. • The proportion of patients in whom steroid–free remission (HBI < 5 or SCCAI = 2) is maintained without surgery throughout at least 12 months. • The proportion of patients in whom remission, as determined by HBI < 5 or SCCAI = 2, CRP < 10 mg/l, FCP < 100 microg/g faeces (or < upper normal limit of the test used) with one course of corticosteroid for a maximum of 3 months is maintained without surgery throughout at least 12 months. • The proportion of patients in whom remission, as determined by the physician, with one course of corticosteroid for a maximum of 3 months is maintained without surgery throughout at least 12 months.	—

Measure

Time frame

The proportion of patients in whom remission (HBI < 5 or SCCAI = 2) is maintained with one course of corticosteroid for a maximum of 3 months without surgery throughout at least 6 months. • The proportion of patients in whom steroid–free remission (HBI < 5 or SCCAI = 2) is maintained without surgery throughout at least 12 months. • The proportion of patients in whom remission, as determined by HBI < 5 or SCCAI = 2, CRP < 10 mg/l, FCP < 100 microg/g faeces (or < upper normal limit of the test used) with one course of corticosteroid for a maximum of 3 months is maintained without surgery throughout at least 12 months. • The proportion of patients in whom remission, as determined by the physician, with one course of corticosteroid for a maximum of 3 months is maintained without surgery throughout at least 12 months.

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Contacts

Public ContactFemke Schepers

Teva Nederland

Femke.Schepers@teva.nl+31 (0)23 5147 350

Outcome results