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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Baricitinib (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms Ra-Balance
  • Sponsors Eli Lilly and Company

    • Most Recent Events

    • 27 Oct 2021 Results (n=3770) assessing safety of baricitinib for the treatment of rheumatoid arthritis from long-term extension study and integrated database (NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT02265705, NCT01721044, NCT01721057, NCT01711359 and NCT01885078), published in the Annals of the Rheumatic Diseases.
    • 25 Nov 2020 Results of post hoc analysis evaluating clinical improvements of Chinese patients treated with baricitinib 4 mg once daily compared with placebo, based on data from a phase 3 study RA BALANCE published in the Advances in Therapy
    • 20 May 2020 Primary endpoint has been met. (Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20))

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