16 results
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…
The primary objective is to determine the safety and the maximum tolerated dose of dasatinib in combination with lenalidomide and low dose dexamethasone in subjects with relapsed or refractory multiple myeloma
Primary:To determine the response rate and response quality of dasatinib monotherapy or dasatinib/fludarabine combination in fludarabine refractory CLL patientsSecundaryTo asses the overall safety profile of this treatment approachTo asses event…
To compare the best confirmed complete cytogenetic response (CCyR) rates within 12 months in newly diagnosed chronic phase CML subjects treated with dasatinib versus imatinib
The main objective of this study is to estimate the rate of response to dasatinib in children and adolescents with certain types of Ph+ leukaemia either whose disease is resistant to, intolerant to or relapsed after previous imatinib therapy or are…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
Assessment of treatment-free remission (persistence of MMR) after second attempt of TKI discontinuation in patients who failed a relapsed in the EURO-SKI study or under EURO-SKI like conditions. Patients must have received at least three years of…
The primary aim of this trial is to determine the recommended safe dose and schedule of ModraDoc006/r in castration-resistant prostate cancer (CRPC) patients. The first 5 CRPC patients in this study showed a different pharmacokinetic profile, as…
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.
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
To examine the effect of oral dasatinib plus quercetin on liver fibrosis as assessed by histology in individuals with biopsy-proven NAFLD with fibrosis by performing a double*blind randomized controlled proof*of*principle study. The primary endpoint…
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.
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…
Primary:Determine the MTD and/or RDE(s) of ABL001:* As a single agent for CML CP and AP patients* In combination with either nilotinib or imatinib or dasatinib in CML CP and AP patients* As a single agent for CML BP patients and Ph+ ALL…
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.