Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10227285" target="_blank" >RIV/00216208:11110/14:10227285 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00098892:_____/14:#0000842 RIV/00159816:_____/14:00061524 RIV/00064165:_____/14:10227285 RIV/00064173:_____/14:N0000032

Výsledek na webu

<a href="http://dx.doi.org/10.1016/S1474-4422(14)70039-0" target="_blank" >http://dx.doi.org/10.1016/S1474-4422(14)70039-0</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S1474-4422(14)70039-0" target="_blank" >10.1016/S1474-4422(14)70039-0</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial

Popis výsledku v původním jazyce

Background In the SELECT trial, disease activity was reduced in patients with multiple sderosis who received dadizumab high-yield process (HYP) for 52 weeks. The primary aim of the SELECTION extension study was to assess the safety and immunogenicity ofextended treatment with dadizumab HYP. This study is registered with ClinicalTrials.gov, number NCT00870740. Findings 517 (91%) of 567 patients who completed the SELECT trial entered SELECTION, of whom 170 were in the treatment initiation group, 173 in the continuous treatment group, and 174 in the washout and re-initiation group. 11 patients in the treatment initiation group (6%), 13 in the continuous treatment group (8%), and ten in the washout and re-initiation group (6%) had any serious adverse event other than relapse of multiple sderosis. One patient in the washout and re-initiation group (300 mg dadizumab HYP) died because of autoimmtme hepatitis; a contributory role of dadizumab HYP could not be exduded. Seven patients tested po

Název v anglickém jazyce

Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial

Popis výsledku anglicky

Background In the SELECT trial, disease activity was reduced in patients with multiple sderosis who received dadizumab high-yield process (HYP) for 52 weeks. The primary aim of the SELECTION extension study was to assess the safety and immunogenicity ofextended treatment with dadizumab HYP. This study is registered with ClinicalTrials.gov, number NCT00870740. Findings 517 (91%) of 567 patients who completed the SELECT trial entered SELECTION, of whom 170 were in the treatment initiation group, 173 in the continuous treatment group, and 174 in the washout and re-initiation group. 11 patients in the treatment initiation group (6%), 13 in the continuous treatment group (8%), and ten in the washout and re-initiation group (6%) had any serious adverse event other than relapse of multiple sderosis. One patient in the washout and re-initiation group (300 mg dadizumab HYP) died because of autoimmtme hepatitis; a contributory role of dadizumab HYP could not be exduded. Seven patients tested po

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

Z - Vyzkumny zamer (s odkazem do CEZ)<br>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

Lancet Neurology

ISSN

1474-4422

e-ISSN

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Svazek periodika

13

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

472-481

Kód UT WoS článku

000335108100013

EID výsledku v databázi Scopus

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