Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023728%3A_____%2F23%3AN0000032" target="_blank" >RIV/00023728:_____/23:N0000032 - isvavai.cz</a>

Výsledek na webu

<a href="https://doi.org/10.3390/jcm12082982" target="_blank" >https://doi.org/10.3390/jcm12082982</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/jcm12082982" target="_blank" >10.3390/jcm12082982</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study

Popis výsledku v původním jazyce

The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)-Likert Pain sub-scores from baseline at week 13 revealed changes of -5.59 and -5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, -0.05 [95% confidence interval, -0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC-Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC-Likert Total score and Physical Function and Stiffness sub-scores, changes in patients' and investigators' global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

Název v anglickém jazyce

Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study

Popis výsledku anglicky

The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)-Likert Pain sub-scores from baseline at week 13 revealed changes of -5.59 and -5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, -0.05 [95% confidence interval, -0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC-Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC-Likert Total score and Physical Function and Stiffness sub-scores, changes in patients' and investigators' global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30218 - General and internal medicine

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2023

Kód důvěrnosti údajů

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

Název periodika

Journal of Clinical Medicine

ISSN

2077-0383

e-ISSN

2077-0383

Svazek periodika

2023

Číslo periodika v rámci svazku

Art. Nr. 2982

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

13

Strana od-do

1-13

Kód UT WoS článku

000977332000001

EID výsledku v databázi Scopus

2-s2.0-85154552416