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
The result's identifiers
Result code in 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>
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
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
Original language description
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
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30226 - Rheumatology
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2018
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
ANNALS OF THE RHEUMATIC DISEASES
ISSN
0003-4967
e-ISSN
1468-2060
Volume of the periodical
77
Issue of the periodical within the volume
4
Country of publishing house
GB - UNITED KINGDOM
Number of pages
5
Pages from-to
495-499
UT code for WoS article
000429731800010
EID of the result in the Scopus database
2-s2.0-85044241799