A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Summary

This is a randomized, double-blind study comparing ABT-494 to placebo in Japanese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response. Following marketing approval of upadacitinib for rheumatoid arthritis in Japan, this study will become a post-marketing clinical study and include a long-term extension period.

Timeline

Start

2016-03-22

Primary completion

2017-08-03

Completion

2022-06-07

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Upadacitinib 7.5 mg; p <0.001; Response Rate Difference 32.7 (95% CI 14.3 to 51.0); Cochran-Mantel-Haenszel NCT02720523 ↗

registry analysis (superiority test); Placebo vs Upadacitinib 15 mg; p <0.001; Response Rate Difference 40.8 (95% CI 23.5 to 58.1); Cochran-Mantel-Haenszel NCT02720523 ↗

registry analysis (superiority test); Placebo vs Upadacitinib 30 mg; p <0.001; Response Rate Difference 37.1 (95% CI 19.4 to 54.9); Cochran-Mantel-Haenszel NCT02720523 ↗

Publications

• Background Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Zhou Y, Othman AA, Pangan AL, Kitamura S, Meerwein S, Tanaka Y. Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase IIb/III study. Rheumatology (Oxford). 2020 Nov 1;59(11):3303-3313. doi: 10.1093/rheumatology/keaa084.
• Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Konishi Y, Chonan S, Ikeda K, Camp HS, Tanaka Y. Long-term safety and efficacy of upadacitinib in Japanese patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: 5-year results from the SELECT-SUNRISE randomised controlled trial. RMD Open. 2025 Nov 4;11(4):e006213. doi: 10.1136/rmdopen-2025-006213.
• Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
• Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Yokoyama M, Pangan AL, Konishi Y, Meerwein S, Tanaka Y. Efficacy and safety of upadacitinib over 84 weeks in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE). Arthritis Res Ther. 2021 Jan 6;23(1):9. doi: 10.1186/s13075-020-02387-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Upadacitinib	Small molecule	7.5 mg	Oral
Subject	Upadacitinib	Small molecule	15 mg	Oral
Subject	Upadacitinib	Small molecule	30 mg	Oral

Indications