19 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 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…
A study to investigate the analgesic effects of buprenorphine and milnacipram in healthy volunteers.
• To determine if the analgesic effects of co-administration of a single oral dose of milnacipran with a single intravenous dose of buprenorphine are higher than those of buprenorphine alone (potentiation) or higher than those of buprenorphine alone…
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…
The primary objective of this study is to compare the acute effects of single doses of methadone (5 and 10 mg) and buprenorphine (0.2 and 0.4 mg) with placebo on driving performance and cognition. Secondary objective is to study the pharmacokinetics…
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 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…
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 primary objective of this phase 2 study in patients with advanced endometrial cancer is to compare the clinical efficacy of MLN0128 + weekly paclitaxel to weekly paclitaxel alone in second- or third-line treatment of advanced, recurrent, or…
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…
• To evaluate the safety and tolerability of Runimotamab when administered as a single agent (Phase Ia) and in combination with trastuzumab (Phase Ib)• To determine the maximum tolerated dose (MTD), to identify the recommended phase II dose (RP2D),…
Primary objectives- To evaluate the effects of buprenorphine on fentanyl induced analgesia using the PainCart test battery in OT patients, when compared to placebo.Secondary objectives- To evaluate the effects of buprenorphine on fentanyl induced…
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…
This study will explore the safety, tolerability, PK, immunogenicity, PD, and preliminary efficacy of RO7428731, in participants with newly diagnosed and recurrent EGFRvIII-positive GBM.
To assess the efficacy of adding subcutaneous TCZ to csDMARD therapy compared with adding oral prednisone (10 mg daily).
This single arm, multi-center, phase II study will determine the efficacy and safety of tisagenlecleucel in adult patients with FL who failed at least 2 prior systemic therapies, including an anti-CD20 antibody (e.g. rituximab) and an alkylating…
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.