A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

Trial Profile

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2017

At a glance

  • Drugs Baricitinib (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms RA-BEGIN
  • Sponsors Eli Lilly
  • Most Recent Events

    • 30 Aug 2017 According to an Incyte Corporation media release, company will file resubmission of NDA to FDA before end of January 2018.
    • 03 Jul 2017 According to an Eli Lilly media release, based on the data from four Phase III trials Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.
    • 17 Jun 2017 Results of post hoc analysis of RA-BEGIN evaluating proportion of patients with structural damage progression using DAS28-CRP in patients with rheumatoid arhtritis presented at the 18th Annual Congress of the European League Against Rheumatism
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