In the framework of the PROMISE (Drugs for PaediatRic MultIple SclErosis) project, a 36-month multi-centre randomized interventional pragmatic trial, the first two paediatric patients have been recruited at the University Hospital Policlinico of Bari. The children affected by multiple sclerosis will be part of the study aimed to evaluate the effectiveness and safety of glatiramer-acetate (GA) compared to interferon-beta (IFN-beta). The study, funded by Agenzia Italiana del Farmaco (AIFA) is coordinated by University Hospital Policlinico of Bari and consists of two phases: a pre-randomization phase foreseeing the screening, the baseline data collection and a treatment phase. Clinical, cognitive, behavioural and MRI (Magnetic Resonance Imaging) data will be collected at the baseline and at each follow-up visit; these data will be included into the Italian Multiple Sclerosis Register.
The final aim of the project is to demonstrate the equivalence or statistic significant differences between IFN-beta 1a weekly i.m. and GA treatments (20mg) on the efficacy and safety outcomes. CVBF and the Italian Network for Paediatric Clinical Trials (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 Ethical 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).