15 results
The purpose of the study is to investigate the effect on the body of enoxaparin manufactured by the Sponsor (this is called pharmacodynamics) and to compare it with the pharmacodynamic effect of Clexane®. In addition, it will be investigated to what…
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…
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 evaluate the cost-effectiveness the current ruling widespread Royal Dutch Physiotherapy Association guideline, in which the combined use of braces and proprioceptive training after ankle sprain treatment is advocated (usual care), against the use…
Functional treatment with a brace and early physiotherapy will result in improved Kujala scores (reflecting better functional outcome with less pain) and SF-36 scores (reflecting higher quality of life) at 1 year compared with plaster immobilization…
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…
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 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 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…
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…
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…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
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…
With this study we hope to improve the closure rate of perianal Crohn*s fistulas.
To evaluate the tofacitinib and infliximab treatment-induced changes in plasma lipids and lipoproteins and to provide insight in the underlying mechanism in relation to the inflammatory status in patients with active UC.