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inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy.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

Estudios culturales, territorios encontrados

601, [2] p. : im?genes en color, cuadros, gr?ficas. Incluye bibliograf?asLa variedad y profundidad de los art?culos... abordan diversos acontecimientos y perspectivas culturales ... brindan al lector la posibilidad de analizar y cuestionar sus propias pr?cticas. La reflexi?n, sustentada en metodolog?as cient?ficas y evidencias emp?ricas, permite ampliar el horizonte cultural y el conocimiento de los fen?menos de actualidad. Sin embargo, la materia prima del an?lisis la proporciona la cultura humana y, como mencionamos ya, es un fen?meno que construimos en conjunto, a lo largo del tiempo, que nos afecta a todos, propiciando cambios en nuestro modo de vida y, en el mejor de los casos, la evoluci?n y desarrollo de nuestra especie. Llegar a ser hombres m?s conscientes del entorno y ciudadanos mejor preparados para afrontar los desaf?os de la civilizaci?n actual es, en suma, el objetivo del estudio de la cultura humana que nos distingue como especie del mundo natural