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A multicenter, randomized, placebo-controlled, double-blind, phase 3 study of SHR0302, a selective Janus
kinase 1 inhibitor, in patients with active rheumatoid arthritis and inadequate response to conventional
synthetic disease-modifying anti-rheumatic drugs Background: SHR0302, a potent selective JAK1 inhibitor, has demonstrated efficacy and safety in treating patients (pts) with
active RA in a phase 2 trial (NCT03254966). Objectives: This multicenter, randomized, placebo-controlled, double-blind phase 3 study (NCT04333771) was conducted
to further assess the efficacy and safety of SHR0302 in pts with moderate to severe active RA who had an
inadequate response to csDMARDs. Methods: Eligible pts, aged 18-75 years, diagnosed with RA according to the 2010 ACR/EULAR criteria, exhibited
moderately to severely active disease, and had an inadequate response to csDMARDs, were randomized (1:1:1)
to receive either a placebo, 4 mg, or 8 mg of SHR0302, administered orally once daily for 24
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