11 results
Primary ObjectiveThe primary objective is to investigate the PK of the MMF * the main metabolite of DMF * following administration of a delayed-and slow-release tablet formulation (FP187-GC) and the marketed enteric-coated delayed release…
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…
The primary objective is to assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1. The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free…
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…
The overall objectives of this study are to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC who are selected according to biomarker status as identified by tissue-based testing.…
The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD. Secondary objectives are determination of the pharmacokinetic/-dynamic profile of IFX and finding predictors of…
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.
The primary objective will be a prolonged mPFS for the TDM-guided dosing cohort versus the standard fixed dosing cohort in the group of patients with an alectinib Cmin below the threshold of< 435 ng/mL. The secondary objectives are…
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.
Study MX39795 will compare the efficacy and safety of molecularly-guided therapy versusstandard platinum-containing chemotherapy in patients with poor prognosis cancer of unknown primary site(CUP; non-specific subset) who have achieved disease…
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.