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The ethical consideration in placebo-controlled studies of antirheumatic drugs is of primary importance. We thank Dr Yazici1 for his questions regarding the ethical aspect of our study.2
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 Evaluation of Drugs for Rheumatoid Arthritis (RA), which is similar to the US Food and Drug Administration's Guidance for Industry RA.3 The US guidance recommends sponsors to limit the use of placebo as a control and consider the use of an active comparator as the control, or the escape to rescue treatment in studies longer than 12 weeks. In the event …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.
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