13 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, in patients with end stage knee osteoarthritis, the in vivo disease (tissue structure) modifying activity of celecoxib, as a selective COX-2 inhibitor, in addition to its inflammation regulatory properties, compared to naproxen as a…
To assess the efficacy and safety of treatment with tocilizumab versus adalimumab, both in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis who have had an inadequate efficacy response to treatment with…
1.To evaluate the influence of epidural blockade with ropivacaine on the pharmacokinetics of propofol.2.To evaluate the influence of epidural blockade with ropivacaine on the pharmacodynamics of propofol. This includes both the sedative and the…
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…
To evaluate the impact of electroencephalographic NarcotrendTM Index (NI) monitoring on the speed of emergence and recovery from PPS for PGE.
The primary objective is to evaluate whether a switching strategy using adalimumab concentration (TDM) is superior to usual care in rheumatoid arthritis patients failing adalimumab treatment with regard to response rates. The secondary objectives…
Primary ObjectiveThis is a confirmatory trial to establish non-inferior efficacy of remimazolam compared with propofol for induction and maintenance of GA for the purpose of elective surgery in patients classes III and IV based on the American…
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion 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 primary objective of the study of this study is to demonstrate that stroma-targeting by tocilizumab in esophageal adenocarcinoma patients with highly activated stroma increases efficacy of chemoradiotherapy measured by pathological response…
To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease progression / stable disease at or after the week 12 assessment; or death at any time.
To assess the efficacy of adding subcutaneous TCZ to csDMARD therapy compared with adding oral prednisone (10 mg daily).