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Hokkaido University Collection of Scholarly and Academic Papers >
Graduate School of Medicine / Faculty of Medicine >
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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
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| 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)
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Submitter: 小池 隆夫
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