학술논문
Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial
Document Type
article
Author
Shaji Sebastian; Laurent Peyrin-Biroulet; Silvio Danese; Séverine Vermeire; Simon Travis; Jean-Frederic Colombel; Brian G Feagan; Vipul Jairath; Guangyong Zou; Geert R D’Haens; William J Sandborn; Gordon W Moran; Christopher Ma; Peter Bossuyt; Daniel Green; Mark S Silverberg; Maria Kłopocka; Marek Horynski; Stefanie C McFarlane; Zhongya Wang; Shashi Adsul; Marcelo Freire; Gabriela Radulescu; Julie Sigler; Jurij Hanžel; Rocio Sedano; Naveen Arya; Melanie Beaton; William Harlan; Rima Petroniene; Lukasz Wolanski
Source
BMJ Open Gastroenterology, Vol 11, Iss 1 (2024)
Subject
Language
English
ISSN
2054-4774
Abstract
Introduction Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC.Methods and analysis In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score