10 results
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…
The primary objective is the Objective tumor response rate (RECIST). Secondary objectives are: duration of overall response, time to tumor progression (TTP), progression free survival (PFS), overall survival, toxicity profile, incidence of…
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,…
The objective of this study is to validate a new patented prototype prosthetic leg on lateral balance control, and to gain insight into lateral balance in prosthetic walking.The following research questions will be investigated:1. What differences…
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…
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).