Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
Chaparro, María (Universidad Autónoma de Madrid)
Donday, María G. (Universidad Autónoma de Madrid)
Barreiro de-Acosta, Manuel (Hospital Clínico Universitario (Santiago de Compostela, Galícia))
Domènech, Eugeni (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Esteve, Maria (Hospital Universitari MútuaTerrassa (Terrassa, Catalunya))
García-Sánchez, Valle (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Nos, Pilar (Hospital Universitari i Politècnic La Fe (València))
Panés, Julián (Hospital Clínic i Provincial de Barcelona)
Martínez, Concepción (Hospital Universitario de la Princesa (Madrid))
P. Gisbert, Javier (Universidad Autónoma de Madrid)

Date:	2019
Abstract:	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inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy.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 versus 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 versus 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 versus 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.
Grants:	Instituto de Salud Carlos III PI15/00560
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Estudi clínic ; recerca ; Versió publicada
Subject:	Anti-tumour necrosis factor ; Inflammatory bowel disease ; Withdrawal
Published in:	Therapeutic Advances in Gastroenterology, Vol. 12 (september 2019) , ISSN 1756-2848

DOI: 10.1177/1756284819874202
PMID: 35154384

10 p, 1.2 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles