Patients will remain in clinical remission after switch to Thiosix
ID
Bron
Verkorte titel
Aandoening
IBD patients, inadequately responding (lack of response and/or intolerance) to standard thiopurine therapy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• Monitor the incidence of NRH in IBD patients using 6-thioguanine as Thiosix
Achtergrond van het onderzoek
• Monitoring of the incidence of NRH in IBD patients using 6-thioguanine as Thiosix
• 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- thioguanine treatment in IBD patients
• Monitoring of patient reported outcomes (PRO)
Doel van het onderzoek
Patients will remain in clinical remission after switch to Thiosix
Onderzoeksopzet
Safety of Thiosix within at least one year follow up
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. 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.
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
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 | NL7572 |
| Ander register | METc VUmc : 2016.182 |