25 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…
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;…
The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of Acute Coronary Syndrome (ACS). This will be assessed for a period of up to 16 weeks (…
The primary objectives of the study are to assess the safety and tolerability of E5555 in subjects with coronary artery disease (CAD) (Revised per Amendment 01).The secondary objectives are to determine the effect of E5555 on (a) the incidence of…
· To determine the efficacy of several doses of Viaskin® Peanut to significantlydesensitize peanut-allergic subjects to peanut after 12 months of EPIT treatment .· To evaluate the safety of a long-term EPIT with Viaskin® Peanut.
Primary Objectives:To determine the efficacy of brigatinib, as evidenced by confirmed objective response rate (ORR), in patients with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.…
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,…
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 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…
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 objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to *85 years) compared to adults (aged 18 to *64 years) with influenza A infection.
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…
Primary Objective:The primary objective of this study is:• To evaluate the efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS).Key Secondary Objective:• To evaluate the effect of namilumab on proportion of subjects on OCS…
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.
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…
Primary Objective:1. To evaluate the efficacy of sonelokimab at 2 different dose levels (120 mg, 240 mg) compared with placebo in the treatment of participants withactive moderate to severe hidradenitis suppurativa.Secondary Objectives:1. To…
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…