Stelara fOr ChRonic AntibioTic rEfractory pouchitiS
Belgium20 participantsStarted 2020-06-15
Plain-language summary
To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject has a history of ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC)
* The subject has pouchitis that is (a) relapsing or (b) chronic antibiotic refractory, defined by an mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline endoscopy visit and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) ≥3 recurrent episodes within the last year, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline endoscopy visit
Exclusion Criteria:
* Crohn's disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectiouw pouchitis, diverting ostomy or mechanical complications of the pouch
* Previous treatment with an anti-IL12/23 or an anti-IL23 antibody
* Any investigational or approved biologic agent within 30 days of baseline
* Nonbiologic investigational therapy or tofacitinib within 30 days prior to baseline
* Active or untreated latent tuberculosis (TB)
* Chronic hepatitis B virus (HBV) infection, chronic hepatitis C virus (HCV) infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient
* Active severe infec…
What they're measuring
1
The percentage of subjects achieving clinically relevant steroid-free remission