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A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase III Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis.

Trial Profile

A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase III Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2021

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At a glance

  • Drugs Etanercept (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms HERA
  • Sponsors Hanwha Chemical

Most Recent Events

  • 08 Oct 2021 Results of meta-analysis of 3 randomized controlled trials (NCT01270997; NCT01895309 & NCT02357069) assessing efficacy and safety of etanercept biosimilars vs. etanercept originators in patients with active rheumatoid arthritis despite treatment with methotrexate, published in the International Journal of Clinical Pharmacology and Therapeutics.
  • 23 Feb 2016 Results published in the Annals of the Rheumatic Diseases
  • 14 Jul 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.

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