29 results
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 study the influence of anti-TNF therapy on the semen quality of IBD patients
The aim of this study is to compare clinical outcomes and cost-effectiveness of two procedures for skin sparing mastectomy with implant reconstruction in a randomized clinical trial. The customary method for one-stage breast reconstruction with…
The objective of this registry is to obtain long-term safety and clinical statusinformation on pediatric patients with IBD (ie, CD, UC, or IC).
To evaluate the efficacy and safety of infliximab dose reduction guided by serial trough level measurements, compared to treatment as usual (no dose reduction), in Crohn*s disease patients who are in stable remission with infliximab maintenance…
The aim of this study is to investigate the host tissue response to the implanted collagen inlay in implant based breast reconstruction. Secondary, we want to investigate if the presence of capsular formation is associated with the presence of…
To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with *standard of care* IFX…
What is the incremental cost effectiveness ratio of the use of etanercept versus infliximab?Are there subgroups of which infliximab or etanercept is more or less cost-effective in daily practice?Primary objectives: 1. To compare clinical efficacy of…
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 primary objective of the study is to demonstrate that patients with very early arthritis have a higher probability of achieving a state of clinical remission at end of infliximab therapy if treated with infliximab plus MTX when compared to MTX…
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…
Primary: To prove that infliximab in combination with azathioprine is superior to azathioprine alone in rapidly inducing a meaningful renal improvement, defined as a reduction in preoteinuria of at least 50%, in patients with membranous SLE…
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…
Primary objective:- To demonstrate that CT-P13 is noninferior to Remicade at Week 6 (Dose 3), in terms of efficacy, asdetermined by the Crohn*s Disease Activity Index (CDAI)-70 response rate.Secondary objectives:-To evaluate long-term secondary…
The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…
Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change at 26 weeks.
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…
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.
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…