Dataset from A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination With Methotrexate Therapy in Subjects With Active Rheumatoid Arthritis Despite Treatment With DMARDs

This study is designed to explore the activity of granulocyte-macrophage colony stimulating
factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential
impact of inhibition of this axis by GSK3196165, and to evaluate whether there are any
differences in the GM-CSF axis between subjects with early RA compared with those with more
established disease. This study also aims to establish the potential impact of GSK3196165 on
inflammatory structural joint damage in the hand/wrist using magnetic resonance imaging
(MRI). This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled
parallel group study. Approximately 40 subjects with active RA despite treatment with
disease-modifying antirheumatic drugs (DMARDs) (including conventional or biologic) will be
randomized into the study, following a screening period of up to 6 weeks. The total treatment
period is up to 10 weeks, with a 12-week follow-up period after the last dose (Week 22).