152 AttackMS natalizumab for the treatment of people with inflammatory demyeli- nation suggestive of multiple sclerosis
| Autor: | Klaus Schmierer, Iman Redha, Victoria Hammond, David Baker, Frederik Barkhof, Richard Hooper, Waqar Rashid, Victoria Singh-Curry, Jeremy Hobart, Gavin Giovannoni |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Journal of Neurology, Neurosurgery & Psychiatry. 93:e2.108 |
| ISSN: | 1468-330X 0022-3050 |
| DOI: | 10.1136/jnnp-2022-abn2.196 |
| Popis: | Background“Hit hard and early” describes first-line use of highly-effective disease-modifying treatment (HE-DMT) in people with multiple sclerosis (pwMS). However, even in treatment-active centres, months pass from diagnosis to HE-DMT losing potentially precious time to facilitate repair and protect CNS tissue from further damage. Diagnostic uncertainty contributes to hesitancy of using HE-DMT acutely. Natali- zumab (Tysabri®) is a rapidly acting HE-DMT with favourable short-term risk profile and fast elimination.AimsTo establish feasibility to enrol people within 14 days of onset of demyelination; to test Tysabri over 24 weeks for safety, efficacy, and to advance mechanistic understanding.MethodsRandomised, double-blind, placebo-controlled phase IIa trial to establish efficacy superiority over placebo at 12 weeks in facilitating remyelination CNS lesions measured using magnetisation transfer ratio. To detect 50% remyelination with 90% power at 5% significance level and 10% drop-out, n=20 par- ticipants per arm will be recruited across three UK sites.ResultsA favourable REC opinion (IRAS #1003822) has been obtained; the trial is due to start recruitment in March 2022. PPI of recently diagnosed pwMS revealed strong support of AttackMS.ConclusionsAttackMS will be the first trial of HE-DMT in people with a first event of demyelination, in a hyper-acute setting. |
| Databáze: | OpenAIRE |
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