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A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

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Trial Profile

A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2024

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Bio-Thera Solutions

    • Most Recent Events

    • 11 Sep 2024 Results published in the Media Release
    • 07 Sep 2024 Results presenting efficacy, safety, immunogenicity, and pharmacokinetic profiles for TP2 (study weeks 24-48), published in the Arthritis Research and Therapy
    • 24 Jun 2024 According to a Biogen media release, based on results from NCT06262477 and NCT03606876, the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.

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