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Extended report: A randomised double-blind multicentre parallel-group prospective study comparing the pharmacokinetics safety and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study

机译：扩展报告：一项随机双盲多中心平行组的前瞻性研究比较了CT-P13和创新药英夫利昔单抗在强直性脊柱炎患者中的药代动力学安全性和疗效：PLANETAS研究

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ObjectivesTo compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS).

机译：目的比较创新型英夫利昔单抗（INX）和与INX相似的生物仿制药CT-P13在活动性强直性脊柱炎（AS）患者中的药代动力学（PK），安全性和疗效。

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期刊名称 BMJ Open Access
作者
Won Park; Pawel Hrycaj; Slawomir Jeka; Volodymyr Kovalenko; Grygorii Lysenko; Pedro Miranda; Helena Mikazane; Sergio Gutierrez-Ureña; MieJin Lim; Yeon-Ah Lee; Sang Joon Lee; HoUng Kim; Dae Hyun Yoo; Jürgen Braun;
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年(卷),期 -1(72),10
年度 -1
页码 1605–1612
总页数 8
原文格式 PDF
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1. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: The PLANETAS study [J] . ParkW., HrycajP., JekaS., Annals of the Rheumatic Diseases: A Journal of Clinical Rheumatology and Connective Tissue Research . 2013,第10期

机译：一项随机，双盲，多中心，平行分组的前瞻性研究，比较了强直性脊柱炎患者中CT-P13和英夫利昔单抗的药代动力学，安全性和疗效：
2. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study [J] . Won Park, Dae Hyun Yoo, Janusz Jaworski, Arthritis Research . 2016,第1期

机译：根据患者报告的结果，CT-P13和参考英夫利昔单抗在强直性脊柱炎患者中的可比长期疗效：随机，平行分组PLANETAS研究的54周结果
3. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study [J] . YooD.H., HrycajP., MirandaP., Annals of the Rheumatic Diseases: A Journal of Clinical Rheumatology and Connective Tissue Research . 2013,第10期

机译：活动性类风湿关节炎患者与甲氨蝶呤合用时，一项随机，双盲，平行组研究证明与创新药英夫利昔单抗相比，CT-P13的疗效和安全性相当：PLANETRA研究
4. Comparable long-term efficacy as assessed by patient-reported outcomes safety and pharmacokinetics of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized parallel-group PLANETAS study [O] . Won Park, Dae Hyun Yoo, Janusz Jaworski, 2016

机译：根据患者报告的结果CT-P13和参考英夫利昔单抗在强直性脊柱炎患者中的可比长期疗效：随机平行分组PLANETAS研究的54周结果
5. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study [O] . Won Park, Dae Hyun Yoo, Janusz Jaworski, 2016

机译：根据患者报告的结果，CT-P13和参考英夫利昔单抗在强直性脊柱炎患者中的可比长期疗效：随机，平行分组PLANETAS研究的54周结果

Extended report: A randomised double-blind multicentre parallel-group prospective study comparing the pharmacokinetics safety and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study

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