20 results
The aim of this study is to explore the incidence of MTX related gastro-intestinal in a large cohort of JIA patients. Secondly, we want to investigate the effect of psychological behavioural therapy or switch to parenteral MTX dosing to ameliorate…
- The main hypothesis of this study is that JIA patients at risk of a flare due to subclinical inflammatory activity may be identified by analysis of the phagocyte activity marker S100A12 and hsCRP. The goal is a stratification of the therapeutic…
The study has the following 3 main objectives pertaining to the treatment of DMARD-naïve subjects with adult-onset, early, active, RA, diagnosed within 1 year before Screening using the 2010 ACR/EULAR RA classification criteria:1.To show that…
The objectives of this study are to determine the safety and efficacy of two doses of adalimumab versus MTX in paediatric subjects with chronic plaque psoriasis, to determine the time to loss of disease control and the ability to regain response…
The study will look at patients with Squamous Cell Head and Neck Cancer (SCCHN) whose tumours express a certain type of protein called PD-L1. The research aims to compare a new drug called nivolumab against Investigator's choice of chemotherapy…
The purpose of the study is to investigate how quickly and to what extent BAY 1834845 is absorbed and eliminated from the body (this is called pharmacokinetics). In both study parts it will also be investigated to what extent BAY 1834845 is…
Primary: *To assess if combination therapy of adalimumab and MTX significantly improves the drug survival at one year compared to adalimumab monotherapy in patients with moderate-to-severe psoriasis.Secondary: *To assess if combination therapy of…
This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a newsequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and byhigh-dose chemotherapy supported by ASCT.
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…
Improvement in OS is generally accepted as the best measure of clinical benefit forpatients with advanced/unresectable or metastatic NSCLC. The assumption thattreatment with MPDL3280A will prolong OS compared with treatment with docetaxel isbased on…
To compare the efficacy and safety of methotrexate versus azathioprine treatment in adult patients with chronic severe AD.
The objectives of this study are:* To determine the percentage of patients with recent-onset RA and UA who achieve and maintain clinical remission on treatment with a combination of methotrexate 25 mg/week and extended prednisone pulse (tapered high…
Objectives. The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and, in particular, of projects designed to discern new models for the successful conduct of clinical trials in…
Primary Objective:- To provide continued access to atezolizumab based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent study closure.Secondary Objectives:- Safety Objective: To evaluate the…
Primary objective: To evaluate the efficacy of MPDL3280A in patients with locally advanced or metastatic solid tumor whom, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti PD-L1 immunotherapy…
To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission.
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
AssessinG Efficacy of carboplatin and ATezOlizumab in metastatic Lobular breast cancer: GELATO-trial
To assess the efficacy of atezolizumab in combination with carboplatin in metastatic ILC
The co-primary objectives of this study are: * To evaluate the efficacy of as measured by investigator-assessed PFS according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). * To evaluate the efficacy of atezolizumab as…
To compare the effectiveness of weekly subcutaneously administered MTX for maintaining relapse-free sustained steroid/EN-free 1-year remission compared with:- daily oral AZA/6MP in low risk paediatric CD- subcutaneously administered adalimumab in…