{"id":27294,"date":"2025-04-07T12:53:55","date_gmt":"2025-04-07T12:53:55","guid":{"rendered":"https:\/\/www.neuraxpharm.com\/it\/?page_id=27294"},"modified":"2026-05-06T06:44:57","modified_gmt":"2026-05-06T06:44:57","slug":"disegno-dello-studio","status":"publish","type":"page","link":"https:\/\/www.neuraxpharm.com\/it\/portafoglio\/sclerosi-multipla\/disegno-dello-studio\/","title":{"rendered":"Disegno dello studio"},"content":{"rendered":"\t\t
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Home<\/a><\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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BRIUMVI\u00ae \u00e8 stato valutato in 2 studi clinici identici globali randomizzati ed di FASE3<\/sup><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\tCriteri di inclusione:\n
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  • Sclerosi multipla recidivante\n<\/li>\n \t
  • Punteggio EDSS (Expanded Disability Status Scale) 0-5,5\n<\/li>\n \t
  • Due o pi\u00f9 recidive nei 2 anni precedenti, oppure\n<\/li>\n \t
  • Una recidiva e\/o almeno 1 lesione T1 con aumento di gadolinio (Gd+) nell’anno precedente lo screening.\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Le valutazioni neurologiche sono state eseguite ogni per 12 settimane e i pazienti sono stati sottoposti a risonanza magnetica (RMN) alle settimane 12, 24, 48 e 96.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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    \n\t\t\t\t\t\t\t\t\t1\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \n\t\t\t\t\t\t\t\t\tEndpoint primario\n<\/strong>\nTasso di ricaduta annualizzato (ARR) a 96 settimane\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    \n\t\t\t\t\t\t\t\t\t2\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Endpoint secondari selezionati
    <\/strong><\/p>

    • Numero di lesioni T1 Gd+ alla settimana 96<\/li>
    • Numero di nuove lesioni T2 iperintense o in aumento alla settimana 96<\/li>
    • Tempo per la progressione confermata della disabilit\u00e0 (CDP) per a 12 settimane<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      I pazienti analizzati in entrambi gli studi avevano caratteristiche demografiche simili al basale<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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      \n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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