A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

本研究旨在明确，对于甲氨蝶呤（methotrexate, MTX）治疗受限或未接受过MTX治疗、且未使用过其他传统或生物类改善病情抗风湿药（disease-modifying antirheumatic drugs, DMARDs）的中度至重度活动性类风湿关节炎（rheumatoid arthritis, RA）患者，单用巴瑞替尼（baricitinib）疗法是否不劣于单用甲氨蝶呤疗法。