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A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2)

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研究单位: [1]AbbVie [2]First Affiliated Hospital of Kunming Medical University /ID# 217945 Kunming,China,650032 [3]AZ Arthritis and Rheumotology Research,PLLC /ID# 215113 Phoenix,Arizona,United States,85032-9306 [4]Arizona Arthritis & Rheumatology Research,PLLC /ID# 214731 Tucson,Arizona,United States,85704 [5]Newport Huntington Medical Group /ID# 216281 Huntington Beach,California,United States,92648 [6]Inland Rheum & Osteo Med Grp /ID# 215807 Upland,California,United States,91786 [7]Denver Arthritis Clinic /ID# 215346 Denver,Colorado,United States,80230 [8]Tekton Research /ID# 215054 Fort Collins,Colorado,United States,80528 [9]Arthritis & Rheumatic Disease Specialties /ID# 215306 Aventura,Florida,United States,33180 [10]Sweet Hope Research Specialty Inc /ID# 215931 Hialeah,Florida,United States,33016-1897

研究目的:
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). To assess the safety and tolerability of upadacitinib in adult participants with active axSpA including bDMARD-IR AS (Study 1) and with nr-axSpA (Study 2). To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and with nr-axSpA who have completed the Double-Blind Period (Study 2). To evaluate the maintenance of disease control after withdrawal of upadacitinib.

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