A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) (SELECT - PsA 1)
研究单位:[1]AbbVie[2]First Affiliated Hospital of Kunming Medical University /ID# 201264 Kunming,China,650032[3]Clinical Res of West FL,Inc. /ID# 159829 Clearwater,Florida,United States,33765[4]International Medical Research - Daytona /ID# 160040 Daytona Beach,Florida,United States,32117[5]Omega Research Maitland,LLC /ID# 164193 DeBary,Florida,United States,32713-2260[6]Precision Research Org,LLC /ID# 161287 Miami Lakes,Florida,United States,33016-1501[7]LeJenue Research Associates /ID# 170965 Miami,Florida,United States,33126[8]Medallion Clinical Research Institute,LLC /ID# 161228 Naples,Florida,United States,34102[9]Millennium Research /ID# 159822 Ormond Beach,Florida,United States,32174[10]Arthritis Center,Inc. /ID# 163465 Palm Harbor,Florida,United States,34684
研究目的:
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression.