A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10218374" target="_blank" >RIV/00216208:11110/14:10218374 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1007/s00415-014-7264-4" target="_blank" >http://dx.doi.org/10.1007/s00415-014-7264-4</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s00415-014-7264-4" target="_blank" >10.1007/s00415-014-7264-4</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

Popis výsledku v původním jazyce

The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFN beta)-1a (Avonex(A (R)) reference arm). RRMS patients age 18-55 yearswith Expanded Disability Status Scale (EDSS) scores of 0-5.5 and documented pre-study relapse (a parts per thousand yen 1 in previous year, 2 in previous 2 years, or 1 in previous 1-2 years and a parts per thousand yen 1 GdE lesion in the previous year)were randomized (1:1:1) to laquinimod 0.6 mg once-daily, matching oral placebo, or IFN beta-1a IM 30 mu g once-weekly (rater-blinded design), for 24 months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFN beta-1a (n = 447). ARR was not significantly reduced with laquinimod [-18 %, risk

Název v anglickém jazyce

A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

Popis výsledku anglicky

The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFN beta)-1a (Avonex(A (R)) reference arm). RRMS patients age 18-55 yearswith Expanded Disability Status Scale (EDSS) scores of 0-5.5 and documented pre-study relapse (a parts per thousand yen 1 in previous year, 2 in previous 2 years, or 1 in previous 1-2 years and a parts per thousand yen 1 GdE lesion in the previous year)were randomized (1:1:1) to laquinimod 0.6 mg once-daily, matching oral placebo, or IFN beta-1a IM 30 mu g once-weekly (rater-blinded design), for 24 months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFN beta-1a (n = 447). ARR was not significantly reduced with laquinimod [-18 %, risk

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FH - Neurologie, neurochirurgie, neurovědy

OECD FORD obor

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Projekt

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Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2014

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Neurology

ISSN

0340-5354

e-ISSN

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Svazek periodika

261

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

DE - Spolková republika Německo

Počet stran výsledku

11

Strana od-do

773-783

Kód UT WoS článku

000334177100018

EID výsledku v databázi Scopus

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