A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

Study Identifier
M13-542
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, German, Hungarian, Polish, Spanish, Turkish

Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Study Drug
  • Placebo
  • Upadacitinib
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years

    Protocol Summary

    The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

    The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

    Study Locations

    Location
    Status
    Location
    Rheum Assoc of North Alabama /ID# 145959
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    AZ Arthritis and Rheum Assoc /ID# 148593
    Mesa, Arizona, United States, 85202
    Status
    Not applicable
    Location
    AZ Arthritis and Rheum Researc /ID# 142816
    Phoenix, Arizona, United States, 85032-9306
    Status
    Not applicable
    Location
    AZ Arthritis and Rheum Researc /ID# 146075
    Phoenix, Arizona, United States, 85032-9306
    Status
    Not applicable
    Location
    AZ Arthritis and Rheum Researc /ID# 148592
    Phoenix, Arizona, United States, 85032-9306
    Status
    Not applicable
    Location
    Arizona Research Center, Inc. /ID# 142741
    Phoenix, Arizona, United States, 85053-4061
    Status
    Not applicable
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