Role of CVBF
PROMISE project is a 36-month multi-centre randomized interventional pragmatic trial aimed to evaluate the effectiveness and safety of glatiramer-acetate (GA) compared to interferon-beta (IFN-beta) in paediatric patients affected by multiple sclerosis. The study is coordinated by Prof. Lucia Margari of the Department of Basic Medical Sciences, Neuroscience and Sense Organs-University of Bari Aldo Moro – University Hospital Policlinico of Bari. It consists of two phases: a pre-randomization phase consisting of screening and baseline data collection and a treatment phase. Clinical, cognitive, behavioural and MRI data will be collected at the baseline and at each follow-up visit; these data will be included into the Italian MS Register. The final aim of the project is to demonstrate the equivalence or statistical significant differences between IFN-beta 1a weekly i.m. and GA treatments on the efficacy and safety outcomes. CVBF and the Italian network for Paediatric Clinical Trial (INCiPiT) to whom CVBF adheres,
will provide several services within this project such as: identification of possible additional centres to meet the recruitment plan, support for Ethics approval and Competent Authority authorisation, preparation of the monitoring plan and performing of monitoring activities, data collection and analysis and any other requirements for clinical trials in accordance with Good Clinical Practice (GCP).
Agenzia Italiana del Farmaco – AIFA
University of Bari Aldo Moro – University Hospital Policlinico of Bari -Italy, CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE – CVBF – Italy, Associazione Italiana Sclerosi Multipla (AISM)- Italy