Efficacy and Safety of Vedolizumab Intravenous in Pediatric Chronic Pouchitis

You may be able to join if

• In the opinion of the investigator, the subject, parent, or legal guardian is capable of understanding and complying with protocol requirements.
• The subject, parent or legal guardian has signed and dated a written, informed consent form and subject assent form and any required privacy authorization before the initiation of any study procedures.
• The subject is aged 2 to 17 years, inclusive, at the time of screening and first dose.
• The subject weighs ≥10 kg at the time of screening and first dose.
• The subject has a history of proctocolectomy and IPAA as treatment for ulcerative colitis (UC), Crohn’s disease (CD), familial adenomatous polyposis, or other underlying conditions, such as Hirschsprung's disease, for which construction of a puch was medically indicated, completed at least 1 year before the screening visit.
• "The subject has active chronic pouchitis, defined by an mPDAI score ≥5 assessed using the average of subject-reported clinical symptoms from 3 days during a 5-day period immediately before screening endoscopy (ie, video pouchoscopy with biopsy) or bowel preparation for endoscopy, and a minimum mPDAI endoscopic subscore of 2 (outside the staple or suture line) and either: a) Has had ≥1 previous episodes of pouchitis within 1 year before the screening visit, with symptoms lasting at least 4 weeks, treated with ≥2 weeks of antibiotic or otherprescription therapy (ie, other antibiotics, probiotics, immunomodulators, or anti-TNFs within 1 year before screening). or b) Has had an inadequate response with, or lost response to, or is intolerant to antibiotic therapy (ie, requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately before the baseline endoscopy visit or not able to receive or continue antibiotic treatment due to intolerance or other contraindication)."