10 results
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…
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…
- To evaluate if co-administration of single-dose almorexant (200 mg) influences the psychomotor and cognitive impairing effects of ethanol (at a blood level of 0.6 g/L for 5 hours) in healthy subjects.-To evaluate the potential PK interactions…
- To evaluate the safety and tolerability of ascending single oral doses of ACT-462206 in healthy male subjects.- To investigate the single oral dose PK and PD of ACT-462206 in healthy male subjects.- To investigate dose proportionality across…
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…
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…
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,…
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…
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).
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…