22 results
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…
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…
The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of tocilizumab in patients with active RA.The secondary objectives of this study are to:I. Assess clinical response at week 16;…
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…
The objective of this study is to evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy.
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).
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 the study is to evaluate the efficacy of REGN3500monotherapy compared with placebo treatment in adult patients withmoderate-to-severe atopic dermatitis (AD).The secondary objectives of the study are:* To evaluate the…
1) To assess uptake of [18F]BMS-986192 in tumor lesions before and after treatment with nivolumab, in relation to [18F]-FDG uptake as potential whole body biomarker for response. 2) To evaluate safety and tolerability of neoadjuvant nivolumab 3) To…
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 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…
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 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),…
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 assess the efficacy of adding subcutaneous TCZ to csDMARD therapy compared with adding oral prednisone (10 mg daily).
The primary objectives of the study by study part are:Part A:To determine the treatment effect of dupilumab compared with placeboin adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures…
This Phase II, open-label, multicenter study, will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with R-CHOP in individuals with ctDNA high-risk DLBCL in the first-line setting. Specific objectives and…