A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active-Comparator Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a stable background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

Rheumatoid Arthritis

The primary endpoint is achievement of DAS28-CRP ≤ 3.2 at Week 12. DAS28-CRP will be calculated based on the values of TJC28, SJC28, PtGA, and hsCRP.

Achievement of ACR50 at Week 12. Achievement of ACR50 response will be determined based on 50% or greater improvement in TJC68 and SJC66 and ≥ 3 of the 5 measures of Patient's Assessment of Pain (past week, NRS), Patient's Global Assessment of Disease Activity (PtGA [past week, NRS]), Physician's Global Assessment of Disease Activity (PhGA [NRS]), HAQ-DI, or hsCRP., Achievement of DAS28-CRP < 2.6 at Week 12, Change from baseline in DAS28-CRP at Week 12, Change from baseline in Patient's Assessment of Pain at Week 12, Change from baseline in HAQ-DI at Week 12

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