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A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis

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Trial Profile

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Infliximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen

    • Most Recent Events

    • 06 Dec 2019 According to an Amgen media release, the U.S. FDA has approved AVSOLA (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
    • 15 Jun 2019 Results evaluating efficacy and safety of ABP 710 presented at the 20th Annual Congress of the European League Against Rheumatism
    • 17 Dec 2018 According to an Amgen media release, the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE (infliximab). Data from the trial supported the submission.

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