Four Phase 3 clinical trials of baricitinib in the treatment of moderate-to-severe active rheumatoid arthritis enrolled patients who were methotrexate-naïve or had inadequate response to methotrexate, conventional disease-modifying antirheumatic drugs (DMARDs) or DMARDs with TNF inhibitors.
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Taylor, Peter C. et al. “Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis”
Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
The NDA for baricitinib was submitted in January 2016 and a 3-month extension for time to review additional analyses was announced in January 2017.
The approval was supported by a clinical program that included dose-ranging trials (Study I and II) and confirmatory Phase 3 trials (Study III and IV).