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
  • Psoriatic Arthritis (PsA)
  • Study Drug
  • Placebo
  • Upadacitinib
  • 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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