32 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 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…
The objective of the BRAVO 2/3 study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
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 study hypothesis is that anticoagulation with bivalirudin for primary PCI in STEMI subjects with a 4 h infusion post-PCI will reduce infarct size compared with anticoagulation with UFH as assessed by CMR 5 days after the index event.The primary…
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…
1) To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients…
The purpose of the trial is to show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in patients with STE-ACS, with an onset of symptoms of >20 minutes and <12 hours,…
To study the influence of anti-TNF therapy on the semen quality of IBD patients
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…
The objective of the study is to determine the non inferiority of TITANOX over EES and to determine the superiority of bivalirudin during 4 hours over bivalirudin during PCI in patients with ACS who are scheduled for primary PCI (STEMI) or for…
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 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…
To evaluate the efficacy of inhaled rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation.
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…
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 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…
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.
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…
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…