52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis.
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023728%3A_____%2F17%3AN0000001" target="_blank" >RIV/00023728:_____/17:N0000001 - isvavai.cz</a>
Result on the web
<a href="http://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=GeneralSearch&qid=1&SID=F69N44Xg31fnPzlwRLV&page=1&doc=1" target="_blank" >http://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=GeneralSearch&qid=1&SID=F69N44Xg31fnPzlwRLV&page=1&doc=1</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1093/rheumatology/kex269" target="_blank" >10.1093/rheumatology/kex269</a>
Alternative languages
Result language
angličtina
Original language name
52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis.
Original language description
A total of 596 patients were randomized to receive either SB4 (n = 299) or ETN (n = 297) and 505 (84.7%) patients completed 52 weeks of the study. At week 52, the ACR20 response rates in the perprotocol set were comparable between SB4 (80.8%) and ETN (81.5%). All efficacy results were comparable between the two groups and they were maintained up to week 52. Radiographic progression was also comparable and the change from baseline in the mTSS was 0.45 for SB4 and 0.74 for ETN. The safety profile of SB4 was similar to that of ETN and the incidence of anti-drug antibody development up to week 52 was 1.0 and 13.2% in the SB4 and ETN groups, respectively.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30226 - Rheumatology
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
RHEUMATOLOGY
ISSN
1462-0324
e-ISSN
1462-0332
Volume of the periodical
56
Issue of the periodical within the volume
12
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
2093-2101
UT code for WoS article
000416628500013
EID of the result in the Scopus database
2-s2.0-85039847709