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

Phase 2

Completed

Conditions: inflammation of the pouch reservoir
Pouchitis
10017969

Registration Number: NL-OMON52963

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

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 (or mPDAI >= 5 if histology is pending) , 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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of patients in clinical and endoscopic<br /><br>remission at week 8. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The main secondary endpoints are changes in histologic disease activity, immune<br /><br>cell infiltration, gene expression of inflammatory cytokines and changes in the<br /><br>microbiome.</p><br>