Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023728%3A_____%2F18%3AN0000026" target="_blank" >RIV/00023728:_____/18:N0000026 - isvavai.cz</a>
Výsledek na webu
<a href="https://ard.bmj.com/content/77/4/495" target="_blank" >https://ard.bmj.com/content/77/4/495</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1136/annrheumdis-2017-212478" target="_blank" >10.1136/annrheumdis-2017-212478</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial
Popis výsledku v původním jazyce
To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). 321 patients were randomised (1:1:1:1) to placebo or tregalizumab 25, 100 or 200mg once-weekly subcutaneously in addition to MTX treatment. Responders at week 12 continued the same treatment, and non-responders at week 12 were escalated to the next higher tregalizumab dose level or re-randomised from placebo to active treatment. After 24weeks, patients could continue treatment with tregalizumab for 24weeks (extension phase). The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. Safety and biological activity were monitored through week 48
Název v anglickém jazyce
Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial
Popis výsledku anglicky
To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). 321 patients were randomised (1:1:1:1) to placebo or tregalizumab 25, 100 or 200mg once-weekly subcutaneously in addition to MTX treatment. Responders at week 12 continued the same treatment, and non-responders at week 12 were escalated to the next higher tregalizumab dose level or re-randomised from placebo to active treatment. After 24weeks, patients could continue treatment with tregalizumab for 24weeks (extension phase). The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. Safety and biological activity were monitored through week 48
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30226 - Rheumatology
Návaznosti výsledku
Projekt
—
Návaznosti
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Ostatní
Rok uplatnění
2018
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
ANNALS OF THE RHEUMATIC DISEASES
ISSN
0003-4967
e-ISSN
1468-2060
Svazek periodika
77
Číslo periodika v rámci svazku
4
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
5
Strana od-do
495-499
Kód UT WoS článku
000429731800010
EID výsledku v databázi Scopus
2-s2.0-85044241799