33 results
The objective of this study is to assess whether sitagliptin may prevent prednisolone-induced impairment of glucose metabolism and beta-cell function.
To compare progression free survival (PFS) of nilotinib and imatinib when used as initial therapy of unresectable and/or metastatic GIST in patients either who have not received prior therapy with TKIs or who have recurrent GIST after stopping…
PRIMARY OBJECTIVEThe primary objective of the study will be to determine the efficacy of 12 weeks of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation…
The aim of the current study is to confirm the CMR rates of nilotinib in newly diagnosed CML-CP patients in a pan-European population using the EUTOS (*European Treatment and Outcome Study for CML*) standardised molecular laboratories. Secondary…
In this trial we will study if treatment with oral corticosteroids or DMSO is effective in decreasing signs and symptoms of CRPS-1. Tolerance of the treatment options and effects on different subtypes of CRPS-1 patients will be evaluated as well.
The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…
The primary objective of the study is to determine the effect of tVNS on the innate immune response elicited by endotoxin (LPS) administration in healthy volunteers up to 24 hours after stimulation.Secondary objectives are to:- Determine effects of…
To evaluate the CCyR rate at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response on imatinib.
Primary* To evaluate whether the efficacy of nilotinib is superior to the control arm (as measured by progression free survivalSecondary* To compare the response rate, and time to response, duration of response, and time to tumor progression of…
Primary: To characterize the PK of nilotinib in pediatric patients with newly diagnosed CP Ph+ CML, with CP or AP Ph+ CML resistant / intolerant to imatinib and/or dasatinib, or with Ph+ ALL refractory/relapsed.Secondary:• To assess the safety and…
Primary objective:To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism and beta-cell function in healthy males
Primary objectives:• To explore whether daily oral treatment with 30 mg prednisolone modulates biomarkers for adverse metabolic effects in a similar manner in patients with chronic atopic dermatitis as compared to healthy volunteers.• To determine…
To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.
Primary objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…
This study is designed to demonstrate equal therapeutic effect of Myfortic® as compared to MMF in this patient group, thus improving therapeutic efficacy.
To evaluate the effect of real-life food consumption on the pharmacokinetics of nilotinib in CML patients
We propose to investigate the effect of administering a broad-acting, potent immune suppressive agent early in the course of the disease as this may prevent neuronal damage caused by low-grade inflammatory processes in the brain. It is expected that…
The primary aim of this research is to demonstrate the noninferiority of anakinra compared with the standard of care in the treatment of acute gout flares.Secondary objectives are to compare the cost per quality-adjusted life day between anakinra…
Primary objective:4To assess the efficacy of AZD9567, 40 mg, compared to prednisolone 20 mg in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological Disease-modifying anti-rheumatic drugs…
To assess the effect of switching CML patients, who have been treated with imatinib *2 years and who have stable detectable molecular residual disease above 0.01% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of…