HUSCAP logo Hokkaido Univ. logo

Hokkaido University Collection of Scholarly and Academic Papers >
Graduate School of Medicine / Faculty of Medicine >
Peer-reviewed Journal Articles, etc >

Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate : the J-RAPID randomized, placebo-controlled trial

This item is licensed under: Creative Commons Attribution 3.0 Unported

Files in This Item:
113_ModRheumatol24_715.pdf629.79 kBPDFView/Open
Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/62839

Title: Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate : the J-RAPID randomized, placebo-controlled trial
Authors: Yamamoto, Kazuhiko Browse this author →KAKEN DB
Takeuchi, Tsutomu Browse this author →KAKEN DB
Yamanaka, Hisashi Browse this author →KAKEN DB
Ishiguro, Naoki Browse this author →KAKEN DB
Tanaka, Yoshiya Browse this author →KAKEN DB
Eguchi, Katsumi Browse this author →KAKEN DB
Watanabe, Akira Browse this author →KAKEN DB
Origasa, Hideki Browse this author →KAKEN DB
Shoji, Toshiharu Browse this author
Sakamaki, Yoshiharu Browse this author
van der Heijde, Désirée Browse this author
Miyasaka, Nobuyuki Browse this author →KAKEN DB
Koike, Takao Browse this author →KAKEN DB
Keywords: Certolizumab pegol
Methotrexate
Randomized controlled trial
Rheumatoid arthritis
Tumor necrosis factor-alpha inhibitor
Issue Date: 2014
Publisher: Informa Healthcare
Journal Title: Modern Rheumatology
Volume: 24
Issue: 5
Start Page: 715
End Page: 724
Publisher DOI: 10.3109/14397595.2013.864224
Abstract: Objectives. This 24-week, multicenter, double-blind, randomized, placebo-controlled study (NCT00791999) compared efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) vs placebo plus MTX in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX. Methods. In total, 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100, 200, or 400 mg (induction dose: 200 mg or 400 mg CZP at Weeks 0, 2, and 4) plus MTX or placebo plus MTX every 2 weeks. Primary endpoint was ACR20 response at Week 12. Results. ACR20 response rates were 62.5%, 76.8%, 77.6%, and 28.6% at Week 12, and 61.1%, 73.2%, 71.8%, and 24.7% at Week 24 for CZP 100, 200, and 400 mg, and placebo groups, respectively, with statistical significance between each CZP group and placebo. Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo. Improvements in health-related quality of life (HRQoL) were observed in all three CZP groups vs placebo. Incidence of adverse events was similar between CZP groups. Conclusions. CZP plus MTX resulted in rapid, sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX, with significant inhibition of radiographic progression and improved HRQoL.
Rights: http://creativecommons.org/licenses/by/3.0
Type: article
URI: http://hdl.handle.net/2115/62839
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小池 隆夫

Export metadata:

OAI-PMH ( junii2 , jpcoar )

MathJax is now OFF:


 

 - Hokkaido University