8 results
To investigate the effect of various dose regimens of Cyclogest® on secretory transformation of the endometrium in comparison to Crinone® and placeboTo investigate single and multiple dose pharmacokinetics of Cyclogest®To investigate safety and…
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…
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…
HV cohort 1Primary Objectives* To characterize the local tolerability of topical bimiralisib after 21 days* To characterize the systemic PK of topical bimiralisib after 21 daysSecondary Objective* To characterize the safety of topical bimiralisib…
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 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.
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.