A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2018

At a glance

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

    • 20 Feb 2018 Results of pooled analysis of NCT00902486, NCT01469013, NCT01185353, NCT01721044, NCT01721057, NCT01711359, NCT01710358 and NCT01885078 trials assessing the effects of baricitinib on the lipid profile, lipoprotein particle size and number, and GlycA published in the Annals of the Rheumatic Diseases
    • 15 Feb 2018 According to an Incyte Corporation media release, in Dec 2017, Eli Lilly announced that they have resubmitted the New Drug Application (NDA) for baricitinib to the U.S.FDA. This was classified as a Class II resubmission, which began a new six-month review cycle.
    • 03 Feb 2018 Results of post hoc subgroup analysis assessing effects of baseline characteristics, including prior bDMARD exposure, on baricitinib efficacy and safety, were published in the Rheumatology.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top