Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial.

IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY BMJ Open Gastroenterology Pub Date : 2024-02-08 DOI:10.1136/bmjgast-2023-001218
Vipul Jairath, Guangyong Zou, Zhongya Wang, Shashi Adsul, Jean-Frederic Colombel, Geert R D'Haens, Marcelo Freire, Gordon W Moran, Laurent Peyrin-Biroulet, William J Sandborn, Shaji Sebastian, Simon Travis, Séverine Vermeire, Gabriela Radulescu, Julie Sigler, Jurij Hanžel, Christopher Ma, Rocio Sedano, Stefanie C McFarlane, Naveen Arya, Melanie Beaton, Peter Bossuyt, Silvio Danese, Daniel Green, William Harlan, Marek Horynski, Maria Klopocka, Rima Petroniene, Mark S Silverberg, Lukasz Wolanski, Brian G Feagan
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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 <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model.

Ethics and dissemination: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings.

Trial registration number: EudraCT: 2019-002485-12; NCT04259138.

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确定溃疡性结肠炎患者的最佳治疗目标:随机对照 VERDICT 试验的原理、设计、方案和中期分析。
简介:溃疡性结肠炎(UC)的治疗目标包括症状、内镜检查和组织学检查。观察性研究表明,与仅获得内镜下缓解相比,获得组织学缓解可能与较低的并发症风险相关。溃疡性结肠炎行动对照试验(VERDICT)旨在确定 UC 患者的最佳治疗目标:在这项多中心、前瞻性随机研究中,660 名中重度 UC 患者(梅奥直肠出血评分[RBS] ≥1;梅奥内镜评分[MES] ≥2)被随机分配到三种治疗目标:无皮质类固醇症状缓解(梅奥 RBS=0)(第 1 组);无皮质类固醇内镜缓解(MES ≤1)和症状缓解(第 2 组);或无皮质类固醇组织学缓解(Geboes 评分 伦理和传播:该研究已获得国家级伦理委员会的批准,或根据各个国家的要求获得个别研究地点伦理委员会的批准。伦理委员会的完整名单可向我们索取。研究结果将在同行评审期刊和科学会议上公布:EudraCT: 2019-002485-12; NCT04259138.
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来源期刊
BMJ Open Gastroenterology
BMJ Open Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
5.90
自引率
3.20%
发文量
68
审稿时长
2 weeks
期刊介绍: BMJ Open Gastroenterology is an online-only, peer-reviewed, open access gastroenterology journal, dedicated to publishing high-quality medical research from all disciplines and therapeutic areas of gastroenterology. It is the open access companion journal of Gut and is co-owned by the British Society of Gastroenterology. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around continuous publication, publishing research online as soon as the article is ready.
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