|The STARS Trial
The comparison of STep-up and step-down therapeutic strategies in childhood ARthritiS trial (STARS) is a new interventional trial aiming to investigate whether an early aggressive therapeutic intervention in children with JIA, based on the initial start of synthetic and biologic DMARDs (Step-down strategy), is superior to an approach based on treatment escalation conducted following the treat-to-target principle (Step-up strategy).
The study is aimed to evaluate, through a pragmatic trial, safety and efficacy of switching from the adalimumab and etanercept originator molecules versus their biosimilar competitors and vice-versa in children with JIA in clinical remission on anti-TNF medication.
The “Single Hub and Access point for paediatric Rheumatology in Europe” (SHARE) is a European project whose main objective is to improve the quality of care of patients suffering from Paediatric Rheumatic Diseases.
PRINTO collected samples of children with JIA newly treated with adalimumab, etanercept or tocilizumab within the project ABIRISK, funded by IMI, which has the aim to investigate antidrug antibody formation in the treatment with biopharmaceuticals
PRINTO is cross-culturally adapting and validating a questionnaire which aims to enable a multidimensional assessment of the disease status and quality of life of children with JIA: the Juvenile Arthritis Multidimensional Assessment Report (JAMAR).
PRINTO and PRES are conducting a pharmacovigilance project which aims at observing children with JIA for 3-10 years undergoing treatment with MTX or biologic agents in order to collect moderate, severe or serious adverse events occurred.
|Juvenile dermatomyositis trial
PRINTO designed the present study as a 5-year phase III single-blind, randomized clinical trial in children with newly diagnosed JDM: prednisone (PDN) versus PDN plus methotrexate, versus PDN plus Cyclosporine A…
The PReS Autoinflammatory Diseases’ Working Group, in collaboration with PRINTO, set up a a web-based international registry for Autoinflammatory diseases.
|Liaisons with pharmaceutical companies
PRINTO is working with pharmaceutical companies as advisor for trials planning, centre selection, data collection, data analysis and interpretation…