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A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade

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A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jan 2023

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At a glance

  • Drugs Infliximab biobetter (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Biomabs Pharmaceuticals

    • Most Recent Events

    • 06 Jan 2023 Results assessing the pharmacokinetic characteristics of CMAB008 and Remicade in healthy subjects and patients with moderately to severely active rheumatoid arthritis (RA) were investigated using a population modeling approach, and the pharmacokinetic similarity of CMAB008 to Remicade from NCT04779892, NCT03478111trials, published in the Advances in Therapy.
    • 17 Mar 2020 Status changed from active, no longer recruiting to completed.
    • 18 Sep 2019 Planned End Date changed from 1 Jul 2019 to 30 Oct 2019.

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