12 results
To evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline hydration prior to TAVI in patients with CKD to prevent CIN.
To evaluate the safety and tolerability of SC TCZ monotherapy and/or in combination with MTX or other non-biologic DMARDs comprising AEs, physical examination, vital signs, and clinical laboratory assessments, including immunogenicity, in patients…
Primary ObjectiveThe primary objective of this study is to compare prospectively in patients treated with TCZ or etanercept (ETA), the time to first occurrence of any component of a composite of major adverse cardiovascular events (MACE) consisting…
Study BP29541 is a first in-human, open-label, multicenter, dose-escalation Phase I clinical study of single-agent RO6958688. The study will be conducted in two parts. Part I of the study is single ascending dose in single patient cohorts to…
Our objective is to investigate the value of a HVIGI in chronic midportion Achilles tendinopathy, using a dubbel-blind, placebo-controlled, randomised clinical trial. We expect that this study design gives us the opportunity to provide solid advise…
EFFICACY OBJECTIVESThe primary efficacy objective for this study is as follows:* To evaluate the efficacy of TCZ compared with placebo on skin sclerosis, as measured by mRSS at Week 48The secondary efficacy objectives for this study are as follows…
The effect of correction of metabolic acidosis in chronic kidney disease on intrarenal RAS activity.
Primary Objective: - To study if sodiumbicarbonate therapy in patients with metabolic acidosis due to chronic kidney disease diminishes intrarenal RAS activity (without affecting the systemic RAS).Secondary Objective(s): - To study if…
The primary objectives of this study are:* To establish the preliminary safety and tolerability profile of RO6958688 in combination with atezolizumab* To determine the maximum-tolerated dose (MTD) in cycle 1 and in later cycles, if achieved, of…
The purpose of the study is to compare these two drugs in view of how quickly and to what extent the drugs are absorbed and eliminated from the body (this is called pharmacokinetics) after injection under the skin of the abdomen.In addition, it will…
Primary: To evaluate the efficacy of tisagenlecleucel therapy as measured by overall response rate by investigator assessment.Secondary: Duration of response, event free survival, relapse free survival, overall survival, safety, kinetics,…
The aim of the study is to assess whether early administration of the drug tocilizumab in SARS-CoV-2 infection (COVID19 - coronavirus) can prevent the risk of death and mechanical ventilation (assisted respiration by a ventilator).
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia. Specific…