View clinical trials related to IBD.
Filter by:The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator. Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks. The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch.
Feasibility study of neuromodulation in patients with IBD.
Over the last decades, there has been an increase in the number of children and youth with mental illness, such as anxiety and depression. Mental illness in youth has a strong negative influence on the youth's quality of life and generally leads to dysfunction in several important areas, such as school and social activities. Early detection and treatment of mental illness entails great treatment benefits, and thus provide opportunity to prevent or reduce individual suffering. Youth who suffer från Medical conditions, such as diabetes, epilepsy, gastro-intestinal disease, and obesity, show an increased risk of developing mental illness. There are well-established, careful programs for examining somatic co-morbidities to diseases in children and youth. Currently, despite the fact that mental illness is more common in these children than medical sequelae and despite that such a procedure is recommended, no routine exist for examining mental health in children and youth presenting for treatment at pediatric clinics in Skåne. The absence of such a general screening entails that mental illness rarely is recognized by medical care providers until it has become severe. The purpose of this study is to describe the prevalence of mental illness in children and adolescents, 11-18 years of age, that undergo Medical treatment at a Clinic for children and youth. Groups recruited for the first part of the study are obesity clinics and gastro clinics. In addition, we want to examine if mental health affects outcome success in their medical treatment. The long-term main objective of this project is early discovery and treatment of mental illness in somatically ill children and youth, thereby preventing the development of severe mental illness, and to reduce suffering. By the end of the project we will have a well-functioning routine for examining mental health status in 11-18 years olds that present for and undergo treatment in Clinics for children and youth in Skåne. Furthermore, we hope that the screening tool can contribute to, and affect, nationally established guide-lines regarding the discovery and treatment of mental illness in children and adolescents within pediatric care.