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

Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Shoji, Toshiharu; Sakamaki, Yoshiharu; van der Heijde, Désirée; Miyasaka, Nobuyuki; Koike, Takao

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

Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi et al.

Modern Rheumatology, 2014, 24(5), 715-724

Permalink : https://hdl.handle.net/2115/62839

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アクセス権	open access
URI	https://hdl.handle.net/2115/62839
タイトル	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
著者	Yamamoto, Kazuhiko ; Takeuchi, Tsutomu ; Yamanaka, Hisashi ; Ishiguro, Naoki ; Tanaka, Yoshiya ; Eguchi, Katsumi ; Watanabe, Akira ; Origasa, Hideki ; Shoji, Toshiharu ; Sakamaki, Yoshiharu ; van der Heijde, Désirée ; Miyasaka, Nobuyuki ; Koike, Takao
e-Rad_Researcher 80191394 著者名 Yamamoto, Kazuhiko
e-Rad_Researcher 50179610 著者名 Takeuchi, Tsutomu
e-Rad_Researcher 10166754 著者名 Yamanaka, Hisashi
e-Rad_Researcher 20212871 著者名 Ishiguro, Naoki
e-Rad_Researcher 30248562 著者名 Tanaka, Yoshiya
e-Rad_Researcher 30128160 著者名 Eguchi, Katsumi
e-Rad_Researcher 70220861 著者名 Watanabe, Akira
e-Rad_Researcher 20245038 著者名 Origasa, Hideki
著者名 Shoji, Toshiharu
著者名 Sakamaki, Yoshiharu
著者名 van der Heijde, Désirée
e-Rad_Researcher 30157622 著者名 Miyasaka, Nobuyuki
e-Rad_Researcher 80146795 著者名 Koike, Takao
言語	英語
キーワード	Certolizumab pegol
	Methotrexate
	Randomized controlled trial
	Rheumatoid arthritis
	Tumor necrosis factor-alpha inhibitor
発行日	2014
出版者	Informa Healthcare
収録物名	Modern Rheumatology
巻(号)	24(5)
ページ	715-724
抄録	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.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
権利情報	Creative Commons Attribution 3.0 Unported
PISSN	1439-7595
NCID	AA1157187X
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.3109/14397595.2013.864224