A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Study Identifier
M15-555
CT.gov Identifier
NCT02706951
EudraCT Identifier
2015-003376-75
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Clinical Study Report
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Plain Language Summary
Available Language(s): English, Polish, Russian, Spanish, Turkish, Japanese
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • Methotrexate
  • Upadacitinib
  • Placebo Upadacitinib
  • Placebo Methotrexate
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of RA for \>= 3 months. * Subjects must have been on oral or parenteral MTX therapy \>= 3 months and on a stable dose for \>= 4 weeks prior to first dose of study drug. * Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) \>= 4 weeks prior to first dose of study drug. * Meets the following minimum disease activity criteria: \>= 6 swollen joints (based on 66 joint counts) and \>= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
    Exclusion Criteria:
    * Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). * Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs). * Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.

    Protocol Summary

    The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX.

    The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.

    Study Locations

    Location
    Status
    Location
    Rheum Assoc of North Alabama /ID# 146009
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Alabama Medical Group, PC /ID# 153941
    Mobile, Alabama, United States, 36608-1787
    Status
    Not applicable
    Location
    ArthroCare Arthritis Care & Re /ID# 143751
    Gilbert, Arizona, United States, 85234
    Status
    Not applicable
    Location
    Elite Clinical Studies, LLC /ID# 143760
    Phoenix, Arizona, United States, 85018
    Status
    Not applicable
    Location
    University of Arizona Cancer Center - North Campus /ID# 147175
    Tucson, Arizona, United States, 85719-1478
    Status
    Not applicable
    Location
    NEA Baptist Womens Clinic /ID# 148904
    Jonesboro, Arkansas, United States, 72401
    Status
    Not applicable
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