A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Study Identifier
M15-554
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Czech, Hungarian, Dutch, Spanish (Chile), Japanese
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol Summary
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.
Study Locations
Location
Status
Location
Alabama Medical Group, PC /ID# 159836
Mobile, Alabama, United States, 36608-1787
Status
Not applicable
Location
Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047
Mesa, Arizona, United States, 85210-6871
Status
Not applicable
Location
Sun Valley Arthritis Center Ltd. /ID# 161203
Peoria, Arizona, United States, 85381
Status
Not applicable
Location
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
Osteoporosis Medical Center /ID# 161411
Beverly Hills, California, United States, 90211
Status
Not applicable
Location
Covina Arthritis Clinic /ID# 159919
Covina, California, United States, 91722
Status
Not applicable
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