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Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial

dc.contributor.authorChaparro, M.
dc.contributor.authorDonday, M. G.
dc.contributor.authorBarreiro de Acosta, Manuel 
dc.contributor.authorDomènech, E.
dc.contributor.authorEsteve, M.
dc.contributor.authorGarcía-Sánchez, V.
dc.contributor.authorNos, P.
dc.contributor.authorPanés, J.
dc.contributor.authorMartínez, C.
dc.contributor.authorGisbert, J. P.
dc.contributor.authorAbad, F.
dc.contributor.authorAguas Peris, M.
dc.contributor.authorAgüero Tejado, E.
dc.contributor.authorAlba, C.
dc.contributor.authorAlbert, M.
dc.contributor.authorAlemán, H.
dc.contributor.authorAlgaba, A.
dc.contributor.authorAlonso Abreu, I.
dc.contributor.authorAmador, M. P.
dc.contributor.authorAmat, M.
dc.contributor.authorAngueira, T.
dc.contributor.authorArajol, C.
dc.contributor.authorArias-González, L.
dc.contributor.authorArrondo Velasco, A.
dc.contributor.authorBaldán, M.
dc.contributor.authorBardán García, B.
dc.contributor.authorBargalló García, A.
dc.contributor.authorBarreiro de Acosta, M.
dc.contributor.authorBarrio Andrés, J.
dc.contributor.authorBastida Paz, G.
dc.contributor.authorBastón Rey, Iria 
dc.contributor.authorBatista, L.
dc.contributor.authorBellver Martínez, M.
dc.contributor.authorBeltrán Niclós, B.
dc.contributor.authorBenítez, J. M.
dc.contributor.authorBer Nieto, Y.
dc.contributor.authorBermejo, F.
dc.contributor.authorBernardo, D.
dc.contributor.authorBlázquez Gómez, I.
dc.contributor.authorBouhmidi Assakali, A.
dc.contributor.authorBusquets Casals, D.
dc.contributor.authorCabriada Nuño, J. L.
dc.contributor.authorCalvet Calvo, X.
dc.contributor.authorCalvo Hernández, M. V.
dc.contributor.authorCalvo, M.
dc.contributor.authorCamps, B.
dc.contributor.authorCarbajo, A. Y.
dc.contributor.authorCardona Peitx, G.
dc.contributor.authorCaro-Patón, T.
dc.contributor.authorCarrillo Palau, M.
dc.contributor.authorCarrión Bolorino, S.
dc.contributor.authorCasanova, M. J.
dc.contributor.authorCasellas Valdé, J. A.
dc.contributor.authorCastaño García, A.
dc.contributor.authorCastro Senosiain, B.
dc.contributor.authorCeballos, D.
dc.contributor.authorCerrillo, E.
dc.contributor.authorChacón Martínez, S.
dc.contributor.authorConsuelo Cañete Pizarro, F.
dc.contributor.authorde Castro Parga, M. L.
dc.contributor.authorde Miguel, M.
dc.contributor.authorde Francisco García, R.
dc.contributor.authorde la Cruz Ramírez, M. D.
dc.contributor.authordel Hoyo Francisco, J.
dc.contributor.authorDelgado Guillena, P.
dc.contributor.authorDesongles Corrales, T.
dc.contributor.authorEcharri Piudo, A.
dc.contributor.authorEspino Paisan, E.
dc.contributor.authorEspona Quer, M.
dc.contributor.authorFernández Pordomingo, A.
dc.contributor.authorFernández Forcelledo, J. L.
dc.contributor.authorFernández-Tomé, S.
dc.contributor.authorFerreiro Iglesias, R.
dc.contributor.authorFerrer Bradley, I.
dc.contributor.authorFerrer, A.
dc.contributor.authorFigueroa, A.
dc.contributor.authorGallach Montero, M.
dc.contributor.authorGarcía Iglesias, P.
dc.contributor.authorGarcía García-Lezcún, C.
dc.contributor.authorGarcía Ramírez, L.
dc.contributor.authorGarcía García, M. J.
dc.contributor.authorGarcía-Bosh, O.
dc.contributor.authorGarre, A.
dc.contributor.authorGiménez Poderós, T.
dc.contributor.authorGómez Irwin, L.
dc.contributor.authorGómez Pastrana, B.
dc.contributor.authorGómez Delgado, E.
dc.contributor.authorGonzález Lama, Y.
dc.contributor.authorGracia García, Á
dc.contributor.authorGracia García, B.
dc.contributor.authorGuardiola, J.
dc.contributor.authorGuerra, I.
dc.contributor.authorGuerra, E.
dc.contributor.authorGuillot, V.
dc.contributor.authorGustmancher Saiz, S.
dc.contributor.authorGutiérrez Casbas, A.
dc.contributor.authorHernández Ramírez, V.
dc.contributor.authorHernando Verdugo, M. M.
dc.contributor.authorHernández Muniesa, B.
dc.contributor.authorHernanz Chaves, R.
dc.contributor.authorHerrera Justiniano, J. M.
dc.contributor.authorHinojosa del Val, J.
dc.contributor.authorIbáñez Feijoo, S.
dc.contributor.authorIborra Colomino, M.
dc.contributor.authorIglesias Flores, E.
dc.contributor.authorIzquierdo García, E.
dc.contributor.authorSampedro González, M. J.
dc.contributor.authorLucendo, A. J.
dc.contributor.authorJiménez García, N.
dc.contributor.authorLeo Carnerero, E.
dc.contributor.authorLoizaga Díaz, I.
dc.contributor.authorLópez de Torre Querejazu, A.
dc.contributor.authorLópez Sánchez, P.
dc.contributor.authorLuis Parras, J.
dc.contributor.authorMaia Boscá, M.
dc.contributor.authorMañosa, M.
dc.contributor.authorMarín Pedrosa, S.
dc.contributor.authorMarín, A.
dc.contributor.authorMarinero, Á
dc.contributor.authorMarín-Jiménez, I.
dc.contributor.authorMárquez Mosquera, L.
dc.contributor.authorMárquez Galán, J. L.
dc.contributor.authorMartín Arranz, E.
dc.contributor.authorMartín Arranz, M. D.
dc.contributor.authorMartínez Cadilla, J.
dc.contributor.authorMartínez Sesmero, J. M.
dc.contributor.authorMartínez Sánchez, B.
dc.contributor.authorMatallana, V.
dc.contributor.authorMateos Hernández, M. I.
dc.contributor.authorMcNicholl, A. G.
dc.contributor.authorMejuto Fernández, R.
dc.contributor.authorMelcarne, L.
dc.contributor.authorMenchén, L.
dc.contributor.authorMéndez-Castrillón Rodríguez, J.
dc.contributor.authorMerino Ochoa, O.
dc.contributor.authorMínguez, M.
dc.contributor.authorMolas Ferrer, G.
dc.contributor.authorMontoro Huguet, M.
dc.contributor.authorMontserrat Torres, A.
dc.contributor.authorMora, F.
dc.contributor.authorMoraleja Yudego, I.
dc.contributor.authorMorales Alvarado, V. J.
dc.contributor.authorMorales Martínez, L.
dc.contributor.authorMorell, A.
dc.contributor.authorMotos García, C.
dc.contributor.authorMuñoz Alonso, F.
dc.contributor.authorMuñoz Villafranca, M. C.
dc.contributor.authorMuñoz, J. E.
dc.contributor.authorMur, A.
dc.contributor.authorNantes, Ó
dc.contributor.authorNavarro, P.
dc.contributor.authorNavarro- Llavat, M.
dc.contributor.authorNos Mateu, P.
dc.contributor.authorNúñez Alonso, A.
dc.contributor.authorNúñez Ortiz, A.
dc.contributor.authorOlivares, D.
dc.contributor.authorOllero Pena, V.
dc.contributor.authorOrobitg, J.
dc.contributor.authorOrtega, L.
dc.contributor.authorOrtiz de Zárate, J.
dc.contributor.authorPallarés Manrique, H.
dc.contributor.authorParadela Carreiro, A.
dc.contributor.authorPeral Ballester, L.
dc.contributor.authorPereira Bueno, S.
dc.contributor.authorPérez Martínez, I.
dc.contributor.authorPineda Mariño, J. R.
dc.contributor.authorPiñero Pérez, C.
dc.contributor.authorPlanas Giner, A.
dc.contributor.authorPlaza Santos, M. R.
dc.contributor.authorPonferrada Díaz, Á
dc.contributor.authorPoza Cardón, J.
dc.contributor.authorPrieto Vicente, V.
dc.contributor.authorPuchades, L.
dc.contributor.authorRamos López, L.
dc.contributor.authorRedondo, S.
dc.contributor.authorRiestra Menéndez, S.
dc.contributor.authorRivero Tirado, M.
dc.contributor.authorRodríguez Lago, I.
dc.contributor.authorRodríguez Gutiérrez, C.
dc.contributor.authorRodríguez, E.
dc.contributor.authorRomero Izquierdo, S.
dc.contributor.authorRubio Iturria, S.
dc.contributor.authorRuiz Antorán, M. B.
dc.contributor.authorRuiz, A.
dc.contributor.authorSalazar, L. F.
dc.contributor.authorSánchez Ulayar, A.
dc.contributor.authorSánchez Gómez, E.
dc.contributor.authorSánchez, C.
dc.contributor.authorSangrador, C.
dc.contributor.authorSerra, K.
dc.contributor.authorSpicakova, K.
dc.contributor.authorSuárez Ferrer, C.
dc.contributor.authorTalavera Fabuel, A.
dc.contributor.authorTaxonera, C.
dc.contributor.authorTordera, M.
dc.contributor.authorTorrella Cortés, E.
dc.contributor.authorTosca, J.
dc.contributor.authorTrigo Salado, C.
dc.contributor.authorUriarte Estefanía, F.
dc.contributor.authorVan Domselaar, M.
dc.contributor.authorVázquez Morón, J. M.
dc.contributor.authorVentura López, P.
dc.contributor.authorVera, M.
dc.contributor.authorVicuña Arregui, M.
dc.contributor.authorVilloria Ferrer, A.
dc.contributor.authorVirgós Aller, T.
dc.contributor.authorYáñez Feria, D.
dc.contributor.authoron behalf of the, Exit study group of Geteccu
dc.date.accessioned2021-11-30T13:13:32Z
dc.date.available2021-11-30T13:13:32Z
dc.date.issued2019
dc.identifier.issn1756-283X
dc.identifier.urihttp://hdl.handle.net/20.500.11940/15787
dc.description.abstractBackground: 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. Methods: 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. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: 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. Clinical trial reference number: EudraCT 2015-001410-10
dc.language.isoenges
dc.rightsAtribución-NoComercial 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/*
dc.titleAnti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trialen
dc.typeArtigoes
dc.contributor.authorcorpPREDICROHN Study Group from GETECCU
dc.authorsophosChaparro, M.
dc.authorsophosDonday, M. G.
dc.authorsophosBarreiro-de Acosta, M.
dc.authorsophosDomènech, E.
dc.authorsophosEsteve, M.
dc.authorsophosGarcía-Sánchez, V.
dc.authorsophosNos, P.
dc.authorsophosPanés, J.
dc.authorsophosMartínez, C.
dc.authorsophosGisbert, J. P.
dc.authorsophosAbad, F.
dc.authorsophosAguas Peris, M.
dc.authorsophosAgüero Tejado, E.
dc.authorsophosAlba, C.
dc.authorsophosAlbert, M.
dc.authorsophosAlemán, H.
dc.authorsophosAlgaba, A.
dc.authorsophosAlonso Abreu, I.
dc.authorsophosAmador, M. P.
dc.authorsophosAmat, M.
dc.authorsophosAngueira, T.
dc.authorsophosArajol, C.
dc.authorsophosArias-González, L.
dc.authorsophosArrondo Velasco, A.
dc.authorsophosBaldán, M.
dc.authorsophosBardán García, B.
dc.authorsophosBargalló García, A.
dc.authorsophosBarreiro de Acosta, M.
dc.authorsophosBarrio Andrés, J.
dc.authorsophosBastida Paz, G.
dc.authorsophosBastón Rey, I.
dc.authorsophosBatista, L.
dc.authorsophosBellver Martínez, M.
dc.authorsophosBeltrán Niclós, B.
dc.authorsophosBenítez, J. M.
dc.authorsophosBer Nieto, Y.
dc.authorsophosBermejo, F.
dc.authorsophosBernardo, D.
dc.authorsophosBlázquez Gómez, I.
dc.authorsophosBouhmidi Assakali, A.
dc.authorsophosBusquets Casals, D.
dc.authorsophosCabriada Nuño, J. L.
dc.authorsophosCalvet Calvo, X.
dc.authorsophosCalvo Hernández, M. V.
dc.authorsophosCalvo, M.
dc.authorsophosCamps, B.
dc.authorsophosCarbajo, A. Y.
dc.authorsophosCardona Peitx, G.
dc.authorsophosCaro-Patón, T.
dc.authorsophosCarrillo Palau, M.
dc.authorsophosCarrión Bolorino, S.
dc.authorsophosCasanova, M. J.
dc.authorsophosCasellas Valdé, J. A.
dc.authorsophosCastaño García, A.
dc.authorsophosCastro Senosiain, B.
dc.authorsophosCeballos, D.
dc.authorsophosCerrillo, E.
dc.authorsophosChacón Martínez, S.
dc.authorsophosConsuelo Cañete Pizarro, F.
dc.authorsophosde Castro Parga, M. L.
dc.authorsophosde Miguel, M.
dc.authorsophosde Francisco García, R.
dc.authorsophosde la Cruz Ramírez, M. D.
dc.authorsophosdel Hoyo Francisco, J.
dc.authorsophosDelgado Guillena, P.
dc.authorsophosDesongles Corrales, T.
dc.authorsophosEcharri Piudo, A.
dc.authorsophosEspino Paisan, E.
dc.authorsophosEspona Quer, M.
dc.authorsophosFernández Pordomingo, A.
dc.authorsophosFernández Forcelledo, J. L.
dc.authorsophosFernández-Tomé, S.
dc.authorsophosFerreiro Iglesias, R.
dc.authorsophosFerrer Bradley, I.
dc.authorsophosFerrer, A.
dc.authorsophosFigueroa, A.
dc.authorsophosGallach Montero, M.
dc.authorsophosGarcía Iglesias, P.
dc.authorsophosGarcía García-Lezcún, C.
dc.authorsophosGarcía Ramírez, L.
dc.authorsophosGarcía García, M. J.
dc.authorsophosGarcía-Bosh, O.
dc.authorsophosGarre, A.
dc.authorsophosGiménez Poderós, T.
dc.authorsophosGómez Irwin, L.
dc.authorsophosGómez Pastrana, B.
dc.authorsophosGómez Delgado, E.
dc.authorsophosGonzález Lama, Y.
dc.authorsophosGracia García, Á
dc.authorsophosGracia García, B.
dc.authorsophosGuardiola, J.
dc.authorsophosGuerra, I.
dc.authorsophosGuerra, E.
dc.authorsophosGuillot, V.
dc.authorsophosGustmancher Saiz, S.
dc.authorsophosGutiérrez Casbas, A.
dc.authorsophosHernández Ramírez, V.
dc.authorsophosHernando Verdugo, M. M.
dc.authorsophosHernández Muniesa, B.
dc.authorsophosHernanz Chaves, R.
dc.authorsophosHerrera Justiniano, J. M.
dc.authorsophosHinojosa del Val, J.
dc.authorsophosIbáñez Feijoo, S.
dc.authorsophosIborra Colomino, M.
dc.authorsophosIglesias Flores, E.
dc.authorsophosIzquierdo García, E.
dc.authorsophosSampedro González, M. J.
dc.authorsophosLucendo, A. J.
dc.authorsophosJiménez García, N.
dc.authorsophosLeo Carnerero, E.
dc.authorsophosLoizaga Díaz, I.
dc.authorsophosLópez de Torre Querejazu, A.
dc.authorsophosLópez Sánchez, P.
dc.authorsophosLuis Parras, J.
dc.authorsophosMaia Boscá, M.
dc.authorsophosMañosa, M.
dc.authorsophosMarín Pedrosa, S.
dc.authorsophosMarín, A.
dc.authorsophosMarinero, Á
dc.authorsophosMarín-Jiménez, I.
dc.authorsophosMárquez Mosquera, L.
dc.authorsophosMárquez Galán, J. L.
dc.authorsophosMartín Arranz, E.
dc.authorsophosMartín Arranz, M. D.
dc.authorsophosMartínez Cadilla, J.
dc.authorsophosMartínez Sesmero, J. M.
dc.authorsophosMartínez Sánchez, B.
dc.authorsophosMatallana, V.
dc.authorsophosMateos Hernández, M. I.
dc.authorsophosMcNicholl, A. G.
dc.authorsophosMejuto Fernández, R.
dc.authorsophosMelcarne, L.
dc.authorsophosMenchén, L.
dc.authorsophosMéndez-Castrillón Rodríguez, J.
dc.authorsophosMerino Ochoa, O.
dc.authorsophosMínguez, M.
dc.authorsophosMolas Ferrer, G.
dc.authorsophosMontoro Huguet, M.
dc.authorsophosMontserrat Torres, A.
dc.authorsophosMora, F.
dc.authorsophosMoraleja Yudego, I.
dc.authorsophosMorales Alvarado, V. J.
dc.authorsophosMorales Martínez, L.
dc.authorsophosMorell, A.
dc.authorsophosMotos García, C.
dc.authorsophosMuñoz Alonso, F.
dc.authorsophosMuñoz Villafranca, M. C.
dc.authorsophosMuñoz, J. E.
dc.authorsophosMur, A.
dc.authorsophosNantes, Ó
dc.authorsophosNavarro, P.
dc.authorsophosNavarro- Llavat, M.
dc.authorsophosNos Mateu, P.
dc.authorsophosNúñez Alonso, A.
dc.authorsophosNúñez Ortiz, A.
dc.authorsophosOlivares, D.
dc.authorsophosOllero Pena, V.
dc.authorsophosOrobitg, J.
dc.authorsophosOrtega, L.
dc.authorsophosOrtiz de Zárate, J.
dc.authorsophosPallarés Manrique, H.
dc.authorsophosParadela Carreiro, A.
dc.authorsophosPeral Ballester, L.
dc.authorsophosPereira Bueno, S.
dc.authorsophosPérez Martínez, I.
dc.authorsophosPineda Mariño, J. R.
dc.authorsophosPiñero Pérez, C.
dc.authorsophosPlanas Giner, A.
dc.authorsophosPlaza Santos, M. R.
dc.authorsophosPonferrada Díaz, Á
dc.authorsophosPoza Cardón, J.
dc.authorsophosPrieto Vicente, V.
dc.authorsophosPuchades, L.
dc.authorsophosRamos López, L.
dc.authorsophosRedondo, S.
dc.authorsophosRiestra Menéndez, S.
dc.authorsophosRivero Tirado, M.
dc.authorsophosRodríguez Lago, I.
dc.authorsophosRodríguez Gutiérrez, C.
dc.authorsophosRodríguez, E.
dc.authorsophosRomero Izquierdo, S.
dc.authorsophosRubio Iturria, S.
dc.authorsophosRuiz Antorán, M. B.
dc.authorsophosRuiz, A.
dc.authorsophosSalazar, L. F.
dc.authorsophosSánchez Ulayar, A.
dc.authorsophosSánchez Gómez, E.
dc.authorsophosSánchez, C.
dc.authorsophosSangrador, C.
dc.authorsophosSerra, K.
dc.authorsophosSpicakova, K.
dc.authorsophosSuárez Ferrer, C.
dc.authorsophosTalavera Fabuel, A.
dc.authorsophosTaxonera, C.
dc.authorsophosTordera, M.
dc.authorsophosTorrella Cortés, E.
dc.authorsophosTosca, J.
dc.authorsophosTrigo Salado, C.
dc.authorsophosUriarte Estefanía, F.
dc.authorsophosVan Domselaar, M.
dc.authorsophosVázquez Morón, J. M.
dc.authorsophosVentura López, P.
dc.authorsophosVera, M.
dc.authorsophosVicuña Arregui, M.
dc.authorsophosVilloria Ferrer, A.
dc.authorsophosVirgós Aller, T.
dc.authorsophosYáñez Feria, D.
dc.authorsophoson behalf of the, Exit study group of Geteccu
dc.identifier.doi10.1177/1756284819874202
dc.identifier.sophos31712
dc.journal.titleTherapeutic advances in gastroenterologyes
dc.organizationServizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de Santiago de Compostela - Complexo Hospitalario Universitario de Santiago de Compostela::Dixestivoes
dc.page.initial1es
dc.page.final10es
dc.relation.publisherversionhttps://journals.sagepub.com/doi/pdf/10.1177/1756284819867848es
dc.rights.accessRightsopenAccesses
dc.subject.keywordCHUSes
dc.typefidesArtículo Originales
dc.typesophosArtículo Originales
dc.volume.number12.es


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