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A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX

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Trial Profile

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Upadacitinib (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms SELECT-MONOTHERAPY
  • Sponsors AbbVie; AbbVie Germany

    • Most Recent Events

    • 12 Jun 2023 Results of post-hoc pooled analysis of 6 studies (NCT02706873, NCT02675426, NCT02629159, NCT02706951, NCT02706847 and NCT03086343) assessing potential risk of upadacitinib in a similar RA population, published in the Annals of the Rheumatic Diseases.
    • 03 Jun 2023 Results assessing efficacy and safety of UPA monotherapy up to wk 260 from the long-term extension (LTE) of SELECT-MONOTHERAPY presented at the 24th Annual Congress of the European League Against Rheumatism
    • 01 May 2023 Results of integrated safety analysis from NCT02706873; , NCT02675426;, NCT02629159; NCT02706951;NCT02706847; NCT03086343, published in the Clinical Rheumatology
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