A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2017

At a glance

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

    • 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 two phase III studies (RA-BUILD and RA-BEAM), assessing the effect of smoking status on efficacy of baricitinib, presented at the 18th Annual Congress of the European League Against Rheumatism
    • 17 Jun 2017 Results assessing the incidence of serious infection events in Baricitinib treated RA patients from across eight studies (n=3492), presented at the 18th Annual Congress of the European League Against Rheumatism
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