Extended report
Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks
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  • Published on:
    Response to Dr Yazici's eLetter: Ethical issue of withholding treatment from patients with active rheumatoid arthritis
    • Tsutomu Takeuchi, Professor
    • Other Contributors:
      • Masayoshi Harigai, Yoshiya Tanaka, Hisashi Yamanaka, Naoki Ishiguro, Kazuhiko Yamamoto, Nobuyuki Miyasaka, Takao Koike, Minoru Kanazawa, Takuya Oba, Toru Yshinari, Daniel Baker and the GO-MONO study group

    Dear Editor,

    The ethical consideration in placebo-controlled studies of antirheumatic drugs is of primary importance. We thank Dr Yazici for his questions regarding the ethical aspect of our study.

    The GO-MONO study was designed to have placebo crossover to methotrexate (MTX) at Week 16, as a Registration Study to Japan Health Authority, following the MHLW Guideline for the Clinical Study and Evaluat...

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    Conflict of Interest:
    None declared.
  • Published on:
    When is it not ethical to withhold treatment for rheumatoid arthritis?

    Dear Editor

    I read with interest the study by Takeuchi et al (1) looking at the role of monotherapy golimumab in Japanese rheumatoid arthritis (RA) patients, who had active disease despite disease modifying anti-rheumatic drug (DMARD) therapy. Inclusion criteria for the study stipulated that patients have 2/3 criteria which were: elevated inflammatory markers, erosions on radiograph or positive serology, in additio...

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    Conflict of Interest:
    None declared.