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A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis

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Trial Profile

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2025

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms Single Transition
  • Sponsors Celltrion

Most Recent Events

  • 23 Feb 2025 According to a Celltrion media release, company announced that the European Commission (EC) has granted marketing authorization for Avtozma for all indications of its reference product, including moderate to severely active rheumatoid arthritis, active systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and giant cell arteritis. The EC approval on Avtozma was supported by a comprehensive data package and totality of evidence, including results from this study.
  • 30 Jan 2025 According to a Celltrion media release, US FDA has approved AVTOZMA (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA, The FDA decision is based on a comprehensive data package and the totality of evidence, including the results from a phase III study demonstrating biosimilarity between AVTOZMA and reference tocilizumab in patients with moderate to severe active RA.
  • 30 Jan 2025 Results presented in the Celltrion Media Release.

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