Portal de Periódicos da CAPES

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

2019; SAGE Publishing; Volume: 12; Linguagem: Inglês

10.1177/1756284819874202

1756-2848

María Chaparro, María G. Donday, Manuel Barreiro‐de Acosta, Eugeni Domènech, María Esteve, Valle García-Sánchez, Pilar Nos, Julián Panés, Concepción Martínez, Javier P. Gisbert, Francisco Abad‐Santos, Mariam Aguas Peris, E. Agüero Tejado, Cristina Alba, Martin Albert, Heriberto Apolinar Alemán, Alicia Algaba, Inmaculada Alonso Abreu, Marina Prieto Amador, Mora Amat, Teresa Angueira, C Aràjol, Laura Arias‐González, A. Arrondo Velasco, Montse Baldán, B. Bardán García, Alvaro Castaño Garcia, Manuel Barreiro‐de Acosta, Jesús Barrio, Gisel Paz, Iria Bastón‐Rey, Lissette Batista, M. Bellver Martínez, Belén Beltrán Niclós, J M Benítez, Yolanda Ber, Fernando Bermejo, David Bernardo, Isabel Blázquez Gómez, A. Bouhmidi Assakali, D. Busquets Casals, José Luis Cabriada Nuño, X. Calvet Calvo, M.V. Calvo Hernández, Marta Calvo, Blau Camps, A Y Carbajo, G Cardona Peitx, T. Caro-Patón, Marta Carrillo‐Palau, Silvia Carrión Bolorino, María José Casanova, J A Casellas Valdé, A. Castaño García, B Castro Senosiain, Daniel Ceballos, Elena Cerrillo, S. Chacón Martínez, F. Consuelo Cañete Pizarro, M L De Castro Parga, Μ. de Miguel, R. de Francisco García, María Dolores de la Cruz Ramírez, Juan Francisco, Pedro Delgado‐Guillena, Teresa Corrales, Ana Echarri, E. Espino Paisán, M. Espona Quer, Alejandra Fernández Pordomingo, José Luis Fernández Forcelledo, Samuel Fernández‐Tomé, Rocío Ferreiro Iglesias, I. Ferrer Bradley, Anna Ferrer, Angélica Figueroa, M. Gallach Montero, Pedro Iglesias, C. García García-Lezcún, L. García Ramírez, María José García, Orlando García-Bosh, A Garre, T. Giménez Poderós, Laura Irwin, B Gomez Pastrana, E. Gómez Delgado, Yago González Lama, Á. Gracia García, B. Gracia García, Jordi Guardiola, Iván Guerra, E. Guerra, Vicente Guillot, S. Gustmancher Saiz, Ana Gutiérrez, Vincent Hernandez Ramirez, M.M. Hernando Verdugo, B Hernández Muniesa, R Hernanz Chaves, José Manuel Herrera Justiniano, Joaquín Hinojosa del Val, S Ibáñez Feijoo, M I Iborra Colomino, Eva Iglesias Flores, E García, M J Sampedro González, Alfredo J. Lucendo, N. Garcia, Eduardo Leo Carnerero, I. Loizaga Díaz, Amaia López de Torre Querejazu, P López Sánchez, Juan Parras, Marta Maia Boscá-Watts, Míriam Mañosa, S Marín Pedrosa, Alicia C Marín, Aída Ramírez, Ignacio Marín‐Jiménez, Lucía Mosquera, JL Márquez Galán, Eduardo Arranz, María Dolores Martín‐Arranz, J Martínez Cadilla, JM Martínez Sesmero, B Martínez Sánchez, Virginia Matallana, MI Mateos Hernández, AG McNicholl, R Mejuto Fernández, Luigi Melcarne, Luís Menchén, J Méndez-Castrillón Rodríguez, Olga Merino Ochoa, Miguel Mínguez, G Molas Ferrer, Miguel Montoro, Antonio Torres, Fabrizio Moro, I. Moraleja Yudego, VJ Morales Alvarado, L Morales Martínez, Alberto Morell, C Motos García, Fabiola Alonso, MC Muñoz Villafranca, J F Muñoz, Antonio Mǔr, Óscar Nantes, Pablo Navarro, M. Navarro Llavat, Pilar Nos Mateu, A Núñez Alonso, Andrea Núñez Ortiz, David Olivares, V Ollero Pena, J Orobitg, L Ortega, Jone Ortiz de Zárate, Héctor Pallarés Manrique, A Paradela Carreiro, L Peral Ballester, S. Pereira Bueno, Isabel Pérez‐Martínez, JR Pineda Mariño, C Piñero Pérez, A. Planas-Giner, MR Plaza Santos, Á Ponferrada Díaz, J Poza Cardón, V Prieto Vicente, Laura Puchades, L. Ramos López, Sara Redondo, S. Riestra Menéndez, Montserrat Rivero, Iago Rodríguez‐Lago, Cristina Rodríguez Gutiérrez, Esther Rodríguez, S Romero Izquierdo, Saioa Rubio Iturria, MB Ruiz Antorán, A Ruiz, L. F. Salazar, A Sánchez Ulayar, E Sánchez Gómez, César Sánchez, C Sangrador, K Serra, Kateřina Špičáková, Cristina Suárez Ferrer, Aurora Talavera Fabuel, Carlos Taxonera, María Tordera, Édgar Cortés, Joan Toscá, Claudio Trigo Salado, F Uriarte Estefanía, Manuel Van Domselaar, JM Vázquez Morón, P Ventura López, Magdalena Vera, Miren Vicuña Arregui, A. Ferrer, T. Virgós Aller, D Yáñez Feria,

Autoimmune and Inflammatory Disorders

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.