16 results
Our primary objective is to determine whether blocking of IL-1 by recombinant human IL-1ra (anakinra) in insulin resistant patients improves insulin sensitivity. Secondary objectives are to determine the effect of IL-1 blockade on pancreatic beta-…
The aim of the Anti-Interleukin-1 in Diabetes Action trial (AIDA) study is to test the feasibility, safety/tolerability and potential efficacy of anti-IL-1 therapy in maintaining or enhancing beta-cell function in people with new-onset Type 1…
Our primary objective is to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
Determine whether blockade of IL-1 had positive effects on insulin sensitivity in type 1 diabetic subjects without residual beta cel function
To investigate the effect on symptomatology of interference with IL-1 in CFS patients.
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The current project proposal continues on our findings of the performed prospective cohort study, aiming to develop a biomarker guided stop strategy for the use of rIL-1RA in sJIA: short and targeted therapy early in the disease course with a yet…
The primary objective is to evaluate the safety and efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). Secondary objectives…
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…
The primary objective is to evaluate the efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). The primary endpoint is the…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
To investigate the efficacy of treatment with human recombinant IL1Ra (rhIL1Ra, Anakinra) in patients with ATC in terms of improved health related quality of life (HRQoL), tumor progression and Overall Survival (OS). Secondary objectives: To…
The aim of ImmunoSep is to study if personalized immunotherapy targeting either fulminant hyper-inflammation or immunoparalysis is able to improve sepsis outcomes.
To determine the effect of anakinra on the development of perihematomal oedema, compared to standard medical management. In an exploratory analysis, we will investigate whether this effect is dose-dependent. Furthermore, to study its effect on serum…