Chaparro María, Donday María G, Barreiro-de Acosta Manuel, Domènech Eugeni, Esteve María, García-Sánchez Valle, Nos Pilar, Panés Julián, Martínez Concepción, Gisbert Javier P
Gastroenterology Department, Hospital Universitario de La Princesa, IIS-IP, Universidad Autónoma de Madrid, CIBEREHD, Madrid, Spain.
Gastroenterology Department, Hospital Clínico Universitario de Santiago de Compostela, Spain.
Therap Adv Gastroenterol. 2019 Sep 13;12:1756284819874202. doi: 10.1177/1756284819874202. eCollection 2019.
Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1 year in patients who discontinue anti-TNF treatment those who continue treatment.
This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn's disease or ulcerative colitis who have achieved clinical remission for ⩾6 months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1 year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal.
Enrolment began in 2016, and the study is expected to end in 2020.
This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission.
EudraCT 2015-001410-10.
使用抗肿瘤坏死因子（抗TNF）药物实现缓解的炎症性肠病患者，可能因安全问题和成本考虑而停药，但缺乏对该策略进行前瞻性、对照研究的数据。主要研究目的是比较停用抗TNF治疗的患者与继续治疗的患者在1年时的临床缓解率。
这是一项正在进行的前瞻性、双盲、多中心、随机、安慰剂对照研究，对象为克罗恩病或溃疡性结肠炎患者，他们使用抗TNF治疗和免疫抑制剂已实现临床缓解≥6个月。患者按1:1随机分组，分别停用抗TNF治疗或继续治疗。随机分组时根据纳入研究时炎症性肠病的类型和药物（英夫利昔单抗与阿达木单抗）对患者进行分层。研究的主要终点是1年时持续临床缓解。其他终点包括内镜和放射学活性、患者报告的结局（生活质量、工作效率）、安全性以及复发的预测因素。所需样本量为194例患者。除主要分析（停药与继续用药）外，亚组分析将包括按炎症性肠病类型、表型和既往治疗进行分层。将获取生物样本以识别停药后复发的预测因素。
入组于2016年开始，预计研究于2020年结束。
本研究将提供关于炎症性肠病患者在临床缓解后停用抗TNF药物后复发结局及预测因素的前瞻性、对照数据。
EudraCT 2015 - 001410 - 10
