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
  • Psoriatic Arthritis (PsA)
  • Study Drug
  • Adalimumab
  • Upadacitinib
  • Placebo to Upadacitinib
  • Placebo to Adalimumab
  • 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
    Showing {first} - {last} of {total} Results