Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis

Amsterdam UMC, location AMC0 个研究点目标入组 12 人开始时间: 2020年9月2日最近更新: 2023年8月21日

试验速览

暂无简介。

•1. Subject has a history of ileal pouch anal anastomosis (IPAA) for UC, all stages completed at least 6 months prior to day one of the start of the study.
•2. Subject has chronic, recurrent and/or antibiotic refractory pouchitis, defined as a PDAI = 7 , with either - = 2 recurrent pouchitis episodes within 1 year prior to screening, necessitating treatment with antibiotics or other prescription, or; - Requiring maintenance antibiotic therapy for = 4 weeks to maintain clinical remission and a history of at least two attempts in the last 24 months to stop this therapy, resulting in a relapse of the pouchitis episodes.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 11
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 1

•1. Pouchitis due to surgery related conditions (such as an abscess, fistula, or sinus of the pouch).
•2. Absence of a previous pelvic MRI to assess secondary causes of pouchitis.
•3. Irritable pouch syndrome (symptoms without evidence of pouchitis on endoscopy and histology).
•4. Mechanical complications of the pouch (e.g. pouch stricture or pouch fistula).
•5. Diverting ileostomy.
•6. Positive stool sample for C. difficile, enteric pathogens, pathogenic ova or parasites at screening.
•7. Active herpes zoster infection or history of disseminated zoster infection.
•8. Evidence of an active infection during screening, or known history of chronic HBV, HCV, HIV infection, or if subject is immunodeficient.
•9. Active or latent infection with Mycobacterium tuberculosis (TB), regardless of treatment history.

发起方

Amsterdam UMC, location AMC