A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

Study Identifier
M13-549
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, Estonian, Chinese (Taiwan), Polish, Russian, Turkish

Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Study Drug
  • Placebo
  • Upadacitinib
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

    Study Locations

    Location
    Status
    Location
    AZ Arthritis and Rheum Assoc /ID# 148651
    Mesa, Arizona, United States, 85202
    Status
    Not applicable
    Location
    SunValley Arthritis Center, Lt /ID# 140452
    Peoria, Arizona, United States, 85381
    Status
    Not applicable
    Location
    AZ Arthritis and Rheum Researc /ID# 138500
    Phoenix, Arizona, United States, 85032-9306
    Status
    Not applicable
    Location
    AZ Arthritis and Rheum Researc /ID# 139286
    Phoenix, Arizona, United States, 85032-9306
    Status
    Not applicable
    Location
    AZ Arthritis & Rheuma Research /ID# 138598
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Arizona Research Center, Inc. /ID# 140448
    Phoenix, Arizona, United States, 85053-4061
    Status
    Not applicable
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