Treatment of refractory pouchitis with tofacitinib

Phase 1

Active, not recruiting

Conditions: Chronic, recurrent and/or antibiotic refractory pouchitis in patients with ulcerative colitis
MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2020-002695-12-NL

Lead Sponsor: Amsterdam UMC, location AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.