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)
Study Identifier
M15-572
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Polish, Turkish, Ukrainian, German (Switzerland), Italian (Switzerland), French (Switzerland), Japanese
Scientific Result Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol Summary
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.
The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
Study Locations
Location
Status
Location
Rheum Assoc of North Alabama /ID# 163231
Huntsville, Alabama, United States, 35801
Status
Not applicable
Location
SunValley Arthritis Center, Lt /ID# 161221
Peoria, Arizona, United States, 85381
Status
Not applicable
Location
AZ Arthritis and Rheumotology Research, PLLC /ID# 159981
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
AZ Arthritis and Rheumotology Research, PLLC /ID# 160033
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
AZ Arthritis and Rheumotology Research, PLLC /ID# 160036
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
AZ Arthritis & Rheuma Research /ID# 160037
Phoenix, Arizona, United States, 85032
Status
Not applicable
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