{"id":1403,"date":"2024-05-10T15:15:32","date_gmt":"2024-05-10T13:15:32","guid":{"rendered":"https:\/\/www.incipit-pediatric.net\/trials\/operetta-2\/"},"modified":"2026-10-19T11:34:13","modified_gmt":"2026-10-19T09:34:13","slug":"operetta-2","status":"publish","type":"trials","link":"https:\/\/www.incipit-pediatric.net\/en\/trials\/operetta-2\/","title":{"rendered":"Operetta 2"},"content":{"rendered":"<p class=\"x_MsoNormal\"><strong><i>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<\/i><\/strong><\/p>\n<p class=\"x_MsoNormal\">Studio di fase III multicentrico, randomizzato, in doppio cieco e con doppia falsa testimonianza per valutare la sicurezza e l&#8217;efficacia di ocrelizumab rispetto a fingolimod in bambini e adolescenti con sclerosi multipla recidivante-remittente<\/p>\n<p class=\"x_MsoNormal\">It is a double-blind phase III study, conducted in countries around the world and sponsored by Roche.<\/p>\n<p class=\"x_MsoNormal\">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.<\/p>\n<p class=\"x_MsoNormal\">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&#8217;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&#8217;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.<\/p>\n<p class=\"x_MsoNormal\">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.<\/p>\n<p>Status: Completed.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>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&#8217;efficacia di ocrelizumab rispetto a fingolimod in bambini e [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-1403","trials","type-trials","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/trials\/1403","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/trials"}],"about":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/types\/trials"}],"wp:attachment":[{"href":"https:\/\/www.incipit-pediatric.net\/en\/wp-json\/wp\/v2\/media?parent=1403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}