Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic (cs)/biologic (b) disease modifying anti-rheumatic drugs (DMARDs)contRAst 2

Key inclusion criteria

• >=18 years of age
• Has had RA for >=6 months and was not diagnosed before 16 years of age
• Has active disease, as defined by having both* − >=6/68 tender/painful joint count (TJC), and − >=6/66 swollen joint count (SJC)
• Has at least 1 bone erosion present on hand/wrist or foot radiographs
• Has had an inadequate response to one or two of the csDMARDs: o methotrexate (MTX) 15–25 mg/week** oral or injected o hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day o sulfasalazine up to 3000 mg/day o leflunomide up to 20 mg/day*** o bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement) o iguratimod up to 50 mg/day * If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC. ** A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement. *** Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons. Key exclusion criteria
• History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren’s syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
• Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
• Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).