22 results
To document the long term safety and efficacy of sarilumab added to DMARDs.
Primary Objective:To compare the clinical benefit of abiraterone acetate plus prednisone versus placebo plus prednisone in patients with chemotherapy-naïve castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic.…
To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with sJIA in order to identifythe dose and regimen for continued development in this population.
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…
To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with pcJIA in order to identifythe dose and regimen for continued development in this population.
The objective of this study is twofold. First, we want to investigate the effectiveness of a COBRA-plus therapy after incomplete response on COBRA-light therapy after 13 weeks to improve the percentage of RA-patients with a high disease activity and…
To evalute the efficacy of rituximab in comparison to continued corticosteroid treatment in ipatients with diopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisolone.
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…
The aim of this study is to assess the correlation between concentrations of prednisolone in blood and saliva in healty adult volunteers and to establish the clinical value of the measurement of prednisolone in saliva as an indicator of individual…
With the goal of improving kidney function and without causing an increased number of rejections, is it possible to reduce tacrolimus dosage through the use of the previously-mentioned immunosupressives after month three.
2.1 Primary ObjectiveDescribing the association between Handscan optical scores, markers of inflammation (levels of CRP, serum IL-6) and clinical swollen joint score in three treatment groups with different pharmacokinetic modes of action for RA…
Main study: to examine whether low dose GC therapy is more effective via the oral route compared to the parenteral route.Dose finding study (pilot study): to examine which oral GC dose is needed for a noticeable decrease in Erythrocyte Sedimentation…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
Primair1. Assessment of the pharmacological activity of BAY·1834845 and BAY 1830839 on IMQ induced skin inflammation compared to placebo (prednisolone serves as active control), as quantified by laser speckle contrast imaging (LSCI, perfusion/basal…
The primary objectives are to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ABBV-621 and to evaluate pharmacokinetics (PK) of (A) single agent ABBV-621; and (B) the combination of ABBV-621 and venetoclax in…
Main objectiveThe primary objective of this study is to assess whether a higher HRQoL, in terms of impact of the disease and its treatment on physical and role functioning, is achieved with metronomic schedules of doxorubicin or cyclophosphamide…
To assess the efficacy and safety of mycophenolate mofetil as induction therapy in patients with treatment naive autoimmune hepatitis.
Primary ObjectivesIn the Dose Escalation Phase:• To assess the safety and pharmacokinetics (PK) in order to determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimabIn…
To determine the efficacy of a short high-dose treatment of oral prednisolone for persistent loss of smell after COVID-19 infection in the long term (>12 weeks). ADD: determining the clinical course/natural recovery of loss of smell and taste…
Primary Objectives* To assess the pharmacodynamic effects of systemic prednisolone on the LPS- or IMQ-induced inflammatory response* To assess safety & tolerability of intradermal LPS and topical IMQ in combination with prednisoloneSecondary…