Clinical and epidemiological research
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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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...
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...