19 results
The objective of this registry is to obtain long-term safety and clinical statusinformation on pediatric patients with IBD (ie, CD, UC, or IC).
The purpose of this study, is to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing*s disease as measured by the proportion of patients achieving normal UFC at the end of the study…
Aim of this study is to investigate the efficacy of *precision dosing* IFX maintenance treatment in comparison with standard IFX maintenance treatment in IBD patients in clinical remission.
Primary objective: Safety.Secondary objective: Efficacy.
PrimaryAssess the safety profile of pasireotide s.c. during the first 8 weeks of treatment with pasireotide s.c.SecondaryAssess the safety profile of pasireotide s.c.at study completionAssess tumor response as measured by disease control rate (DCR)…
Therefore, we aim to investigate in a pilot trial the effect of SOM230 on predefined endpoints in patients with moderate to severe GO whom have contraindications for prednisolone therapy or decline from prednisolone therapy for other reasons.
To study the influence of anti-TNF therapy on the semen quality of IBD patients
Primary To evaluate the treatment effect of pasireotide s.c. on plasma glucose levels during GTT at the end of s.c. dose escalation phase.Secondary: Pulse rate, hematocrit, insulin, glucagon, GLP-1 and GIP secretion during GTT at the end of s.c.…
This study aims to show that the IFX or AZA are equally effective with the latter being more efficient as maintenance therapy in CD after remission induction with IFX/AZA for at least 6 months as defined by the proportion of patients not needing…
The objective of the study is to improve medical treatment of Cushing's disease by combining partially independent medical therapies which act through differential mechanisms. Given the high affinity of SOM230 to sst5 and considering the facts…
At present there are no validated parameters that predict how a patient will respond to inflixmab treatment.In this study they like to investigate why a certain persentige of patients do have a disease flaire. This suggests that infliximab levels in…
The aim of this study is to assess the effects and costs over a period of 1 to 2 years of laparoscopic ileocecal resection and compare these with those for infliximab therapy in patients with Crohn*s disease refractory to conventional therapy and…
The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.Secundary objectives are determination of PK data and predictors of response to IFX in pediatric CD.
To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than 8 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and…
To assess the number of patients in remission, 12 months after dose adjustment of IFX from 5mg/kg to 3 mg/kg. Secondary objectives include: number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, subsequently…
Currently, there is no guideline for the treatment of perianal Crohn's fistulas. the aim of this study, in which surgical strategies (seton drainage and surgical closure with advancement plasty/LIFT) will be compared to medical treatment. We…
With this study we hope to improve the closure rate of perianal Crohn*s fistulas.
To determine 1) interindividual variation in pharmacokinetic parameters in patients with non-detectable trough levels of IFX and 2) whether the area under the curve (AUC) of the IFX serum concentration during one infusion cycle predicts relapse…
The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure (=therapeutic trough levels) without treatment escalation in pediatric CD patients.