Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis A Randomized Phase IIa Trial
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F15%3A10295596" target="_blank" >RIV/00216208:11110/15:10295596 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00023728:_____/15:#0005020
Výsledek na webu
<a href="http://dx.doi.org/10.1002/art.39083" target="_blank" >http://dx.doi.org/10.1002/art.39083</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1002/art.39083" target="_blank" >10.1002/art.39083</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis A Randomized Phase IIa Trial
Popis výsledku v původním jazyce
Objective. Interleukin-20 (IL-20) is implicated in the pathogenesis of rheumatoid arthritis (RA). The efficacy, safety, and tolerability of NNC0109-0012, a selective anti-IL-20 recombinant human monoclonal antibody (mAb), were assessed in patients with active RA who had an inadequate response to methotrexate therapy. Methods. Sixty-seven patients with RA were enrolled and randomized (2:1) to receive NNC0109-0012 (3 mg/kg per week, subcutaneously) or placebo in a phase IIa, double-blind, 12-week trial with a 13-week followup. The primary end point was change in the Disease Activity Score in 28 joints based on C-reactive protein level (DAS28-CRP) from baseline to week 12. Results. In patients treated with NNC0109-0012, the primary end point, improvementin the DAS28-CRP at week 12, was achieved (estimated difference -0.88; P=0.02), with significant improvement starting at week 1. A greater response was observed in seropositive patients (estimated difference -1.66; P<0.001), which was sus
Název v anglickém jazyce
Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis A Randomized Phase IIa Trial
Popis výsledku anglicky
Objective. Interleukin-20 (IL-20) is implicated in the pathogenesis of rheumatoid arthritis (RA). The efficacy, safety, and tolerability of NNC0109-0012, a selective anti-IL-20 recombinant human monoclonal antibody (mAb), were assessed in patients with active RA who had an inadequate response to methotrexate therapy. Methods. Sixty-seven patients with RA were enrolled and randomized (2:1) to receive NNC0109-0012 (3 mg/kg per week, subcutaneously) or placebo in a phase IIa, double-blind, 12-week trial with a 13-week followup. The primary end point was change in the Disease Activity Score in 28 joints based on C-reactive protein level (DAS28-CRP) from baseline to week 12. Results. In patients treated with NNC0109-0012, the primary end point, improvementin the DAS28-CRP at week 12, was achieved (estimated difference -0.88; P=0.02), with significant improvement starting at week 1. A greater response was observed in seropositive patients (estimated difference -1.66; P<0.001), which was sus
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FP - Ostatní lékařské obory
OECD FORD obor
—
Návaznosti výsledku
Projekt
—
Návaznosti
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Ostatní
Rok uplatnění
2015
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Arthritis & Rheumatology
ISSN
2326-5191
e-ISSN
—
Svazek periodika
67
Číslo periodika v rámci svazku
6
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
11
Strana od-do
1438-1448
Kód UT WoS článku
000355328400006
EID výsledku v databázi Scopus
2-s2.0-84929849291