6-TG will be a beneficial therapy in about two-thirds of IBD patients whom failed previous therapies, consistent with the literature.
ID
Bron
Verkorte titel
Aandoening
IBD patients, inadequately responding (lack of response and/or intolerance) to standard thiopurine therapy, naïve on 6-TG treatment.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
- 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)
Doel van het onderzoek
6-TG will be a beneficial therapy in about two-thirds of IBD patients whom failed previous therapies, consistent with the literature.
Onderzoeksopzet
Efficacy at 6 months, sustained clinical efficacy within 12 months.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7551 |
| Ander register | METc VUmc : 2016.181 |