Study summary

The purpose of this study is to verify the superiority of ASP015K in combination with MTX or with other disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response or intolerance to MTX, as measured by the American College of Rheumatology (ACR) 20 response rate at Week 24.

This study will also evaluate the pharmacokinetics and safety of ASP015K as well as efficacy and safety of long-term treatment with ASP015K (52 weeks).

Additional Study Details

Phase
Phase 3
Product
  • Peficitinib
  • Plaebo
  • Disease-modifying antirheumatic drugs (DMARDs)
  • Type
    Interventional
    Masking
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Enrollment number
    385
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A Study to Assess Safety and Efficacy of ASP015K in Participants with Rheumatoid Arthritis (RA) who Had an Inadequate Response or Intolerance to Methotrexate (MTX)? Contact us by filling out your information to the right and we’ll respond to you.

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      Completed
      Site CN00069
      Jining, China
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      Site CN00067
      Xining, China
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      Site TW00025
      Taipei, Taiwan, Province of China
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      Site CN00071
      Guangdong, China
      Completed
      Site TW00026
      Taipei, Taiwan, Province of China
      Completed
      Site CN00062
      Tianjin, China
      Completed
      Site CN00053
      Sichuan, China
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      Site CN00076
      Chenzhou, China
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      Site CN00065
      Xuzhou, China
      Completed
      Site CN00016
      Guangzhou, China
      Completed
      Site KR00036
      Incheon, Republic of Korea
      Completed
      Site CN00046
      Kunming, China
      Completed
      Site CN00050
      Bengbu, China
      Completed
      Site KR00037
      Gwangju, Republic of Korea
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      Site CN00057
      Tianjin, China
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      Site CN00070
      Nanjing, China
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      Site KR00035
      Seoul, Republic of Korea
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      Site CN00059
      Wuhan, China
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      Site TW00022
      Taichung, Taiwan, Province of China
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      Site CN00049
      Zhuzhou, China
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      Site CN00061
      Changchun, China
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      Site KR00034
      Seoul, Republic of Korea
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      Site CN00052
      Guangzhou, China
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      Site CN00074
      Jieyang, China
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      Site CN00054
      Beijing, China
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      Site CN00063
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      Site CN00068
      Ningbo, China
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      Site KR00033
      Seoul, Republic of Korea
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      Site CN00075
      Pingxiang, China
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      Site CN00073
      Zhengzhou, China
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      Site TW00024
      Taichung, Taiwan, Province of China
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      Site CN00028
      Jilin, China
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      Taichung, Taiwan, Province of China
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      Site CN00045
      Beijing, China
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      Site CN00066
      Qingdao, China
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      Site CN00058
      Inner Mongolia, China
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      Site CN00032
      Changsha, China
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      Site CN00047
      Shantou, China
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      Site CN00064
      Jiujiang, China
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      Site CN00056
      Shanghai, China
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      Site CN00048
      Anhui, China
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      Site CN00060
      Nanjing, China

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