A phase III multicenter, randomized, double-blind, double-dummy study to evaluate safety and efficacy of ocrelizumab in comparison with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis

Studio di fase III multicentrico, randomizzato, in doppio cieco e con doppia falsa testimonianza per valutare la sicurezza e l’efficacia di ocrelizumab rispetto a fingolimod in bambini e adolescenti con sclerosi multipla recidivante-remittente

It is a double-blind phase III study, conducted in countries around the world and sponsored by Roche.

The aim of this study is to compare the effects, positive or negative, of the study drug compared to the comparator drug in the treatment of relapsing-remitting multiple sclerosis (RRMS) in children and adolescents.

Multiple sclerosis (MS) is an unpredictable, sometimes disabling autoimmune disease that affects the nervous system. Most children and adolescents with MS have a type of MS called relapsing-remitting MS (RRMS). RRMS is the most common type of MS and is known to have periods in which new or existing symptoms worsen (relapse), followed by a recovery period in which there are few or no symptoms (remission). Durante le recidive della SMRR, il sistema immunitario attacca le fibre nervose e During RRMS relapses, the immune system attacks nerve fibers and causes inflammation (or swelling), causing MS symptoms. In people with MS the body’s immune system attacks and damages a fatty substance that surrounds and protects the nerves, called myelin. As a result, the nerve impulses (or messages) going to and from the brain are unclear or interrupted, like a frayed electrical cord that isn’t working properly. 233 children and adolescents from all over the world affected by RRMS aged between 10-17 years will participate in the study.

The study drug and the comparator are medicines that temporarily reduce inflammation caused by the immune system and are intended to reduce the frequency of relapses.