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A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

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Trial Profile

A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Oct 2021

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At a glance

  • Drugs Infliximab (Primary) ; Methotrexate; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms PLANETRA
  • Sponsors Celltrion

    • Most Recent Events

    • 09 Sep 2020 Results of two trials ( PLANETRA and PLANETAS)published in the Journal of Clinical Pharmacology
    • 06 Jun 2020 Result of post-hoc analysis of 1-Year results from a part 2 of phase I/III randomized controlled trial presented at the 21st Annual Congress of the European League Against Rheumatism
    • 05 Apr 2016 According to an FDA media release, infliximab (Inflectra) has been approved for multiple indications, including treatment of patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.
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