A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

Study Identifier
M15-925
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, Spanish (Argentina), Spanish (Mexico), Dutch, Portuguese (Brazil), Turkish

Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Study Drug
  • Abatacept
  • Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
  • Upadacitinib
  • Placebo for upadacitinib
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.

    Study Locations

    Location
    Status
    Location
    SunValley Arthritis Center, Lt /ID# 154558
    Peoria, Arizona, United States, 85381
    Status
    Not applicable
    Location
    AZ Arthritis & Rheum Research /ID# 156539
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    AZ Arth & Rheum Res /ID# 167161
    Tucson, Arizona, United States, 85704
    Status
    Not applicable
    Location
    CHI St. Vincent Medical Group /ID# 154561
    Hot Springs, Arkansas, United States, 71913-6999
    Status
    Not applicable
    Location
    Saint Jude Heritage /ID# 158833
    Fullerton, California, United States, 92835
    Status
    Not applicable
    Location
    Kotha and Kotha /ID# 154573
    La Mesa, California, United States, 91942
    Status
    Not applicable
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