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

Background: 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inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy.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 2015-001410-1

?El inicio de un procedimiento contencioso administrativo debido a la clasificaci?n arancelaria de una mercanc?a exportada es una causal de suspensi?n del plazo del r?gimen de restituci?n simplificada de derechos arancelarios - Drawback?

Partiendo del Principio de Facilitaci?n del Comercio Exterior regulado en la Ley General de Aduanas, la Administraci?n Aduanera debe promover el desarrollo nacional a trav?s de la correcta prestaci?n de sus servicios; no obstante, en casos cuando el exportador pretende acogerse al r?gimen del Drawback y para ello debe defender la clasificaci?n arancelaria de la mercanc?a a trav?s de un procedimiento contencioso administrativo, la defensa de este se ve afectada cuando el procedimiento en menci?n no es considerado como causal de suspensi?n del plazo para acogerse al referido r?gimen. El objetivo de esta investigaci?n es demostrar la situaci?n de indefensi?n en la que se encuentra el exportador y la necesidad de cambio de criterio de interpretaci?n de la norma por parte de la Administraci?n Aduanera y el Tribunal Fiscal, lo cual conlleva a determinar como el inicio de un procedimiento contencioso administrativo debe ser considerado causal de suspensi?n del plazo para acogerse al r?gimen del Drawback. La presente investigaci?n utiliz? un m?todo cualitativo descriptivo: te?rico, anal?tico y inductivo. El an?lisis muestra que la Administraci?n Aduanera est? realizando una interpretaci?n literal del art?culo 138 de la Ley General de Aduanas que genera un perjuicio en el r?gimen del Drawback; perjuicio que esta investigaci?n pretende resolver