20 results
Primary objectives of INTACT III are:1) to prospectively compare the efficacy of Sacral Nerve Stimulation (SNS) with BOTOX® 100 U related to the Patient Perception of Bladder Condition (PPBC) questionnaire (Coyne 2006) and the reduction of urinary…
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 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.
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 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 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 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…
To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…
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 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…
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.
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…
Phase 2: To evaluate progression-free survival (PFS) as the primary efficacy measure of MLN1117 plus docetaxel versus docetaxel alone in patients with advanced NSCLC
With this study we hope to improve the closure rate of perianal Crohn*s fistulas.
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…
To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.