A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.
The study included a 35-day screening period; a 56-week blinded period which included 24 weeks of randomized, double-blind, parallel-group, placebo-controlled treatment followed by an additional 32 weeks of treatment blinded to the dose of upadacitinib (Period 1); a long-term extension period of up to a total treatment duration of up to approximately 3 years (Period 2); and a 30-day follow-up call or visit.
All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures. All participants receiving upadacitinib 30 mg QD during Period 2 were switched to upadacitinib 15 mg QD following a protocol amendment and were pooled for AE reporting.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85032-9306, United States
Aventura, Florida 33180, United States
Skokie, Illinois 60076, United States
Summerville, South Carolina 29486-7887, United States
College Station, Texas 77845, United States
Uberlândia, Minas Gerais 38400-902, Brazil
Ribeirão Preto, São Paulo 14051-140, Brazil
São Paulo, 05403-000, Brazil
Providencia, Aysén 7500571, Chile
Győr, Győr-Moson-Sopron 9024, Hungary
Rome, Roma 00128, Italy
Ancona, 60126, Italy
Catania, 95123, Italy
Kitakyushu-shi, Fukuoka 802-8561, Japan
Kitakyushu-shi, Fukuoka 807-8556, Japan
Asahikawa-shi, Hokkaido 078-8510, Japan
Hirakata-shi, Osaka 573-1191, Japan
Kawachinagano Shi, Osaka 586-8521, Japan
Osaka, Osaka 550-0006, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Chuo-ku, Tokyo 104-8560, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Leeuwarden, South Holland 8934 AD, Netherlands
Vila Nova de Gaia, Porto District 4434-502, Portugal
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
Lisbon, 1349-019, Portugal