An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials.

Rocio SedanoChristopher Ma Rish K PaiGeert D' HaensLeonardo GuizzettiLisa M ShackeltonJulie RemillardPaolo GionchettiIlyssa O GordonStefan HolubarMaia KayalGregory Y LauwersReetesh K PaiDarrell S Pardi Mark A SamaanDavid F SchaefferBo ShenMark S SilverbergBrian G Feagan William J Sandborn Vipul Jairath

Published in: Alimentary pharmacology & therapeutics (2021)

We conducted a RAND/UCLA appropriateness process to help inform measurement of pouchitis disease activity within clinical trials and foster the development of novel therapies.

Keyphrases

disease activity
clinical trial
systemic lupus erythematosus
rheumatoid arthritis
rheumatoid arthritis patients
ankylosing spondylitis
juvenile idiopathic arthritis
phase ii
open label
study protocol
double blind
phase iii
randomized controlled trial