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Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

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Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2021

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At a glance

  • Drugs Etanercept (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors LG Life Sciences

    • 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.
    • 19 Dec 2017 Primary endpoint (Disease activity score based on a 28 joint count (DAS28)) has been met as per the results published in the Annals of the Rheumatic Diseases
    • 19 Dec 2017 Status changed to completed.

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