Available datapackage for study 'A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis'

The objectives of Period 1 were the following:

- To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy
(for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus
weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in
methotrexate-naïve adults with moderately to severely active RA;

- To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD
monotherapy versus weekly methotrexate monotherapy for prevention of structural
progression in methotrexate-naïve adults with moderately to severely active RA.

The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of
upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults
with RA who have completed Period 1.