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.
abstract: OBJECTIVE
  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.
authors: Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo , Bunkyo-ku, Tokyo , Japan.
authors: Kazuhiko
authors: K
authors: Yamamoto
authors: Tsutomu
authors: T
authors: Takeuchi
authors: Hisashi
authors: H
authors: Yamanaka
authors: Naoki
authors: N
authors: Ishiguro
authors: Yoshiya
authors: Y
authors: Tanaka
authors: Katsumi
authors: K
authors: Eguchi
authors: Akira
authors: A
authors: Watanabe
authors: Hideki
authors: H
authors: Origasa
authors: Toshiharu
authors: T
authors: Shoji
authors: Yoshiharu
authors: Y
authors: Sakamaki
authors: Désirée
authors: D
authors: van der Heijde
authors: Nobuyuki
authors: N
authors: Miyasaka
authors: Takao
authors: T
authors: Koike
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D001175:Arthrography; D000068582:Certolizumab Pegol; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol; D008727:Methotrexate
keywords: Certolizumab pegol; Methotrexate; Randomized controlled trial; Rheumatoid arthritis; Tumor necrosis factor-alpha inhibitor