No registrations found.
ID
Source
Brief title
Health condition
IBD patients, inadequately responding (lack of response and/or intolerance) to standard thiopurine therapy, naïve on 6-TG treatment.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
- Examine the effectiveness of 6-thioguanine for maintenance treatment in 6-TG naïve UC and CD patients
- Examine the effectiveness of the current dosing scheme for 6-thioguanine in 6-TG naïve IBD patients
- Compare the effectiveness of 6-TG with effectiveness of methotrexate (MTX) in CD patients (historical matched control)
- Characterize the IBD patient population for which 6-thioguanine maintenance therapy is beneficial
- Monitoring of ADRs, SAE, signs of liver toxicity and NRH during 6-TG maintenance treatment in 6-TG naïve IBD patients
- Monitoring of patient reported outcomes (PRO)
Study objective
6-TG will be a beneficial therapy in about two-thirds of IBD patients whom failed previous therapies, consistent with the literature.
Study design
Efficacy at 6 months, sustained clinical efficacy within 12 months.
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7551 |
| Other | METc VUmc : 2016.181 |