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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2017

At a glance

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

    • 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.
    • 13 Jun 2015 Results of retrospective analysis of pooled data from PLANETAS and PLANETRA trials presented at the 16th Annual Congress of the European League Against Rheumatism.
    • 01 Jun 2015 Celltrion received approval from the National Health Surveillance Agency in Brazil for Remsima (infliximab), according to a Hospira media release.
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