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A Phase III confirmatory safety and efficacy study in ankylosing spondylitis

Trial Profile

A Phase III confirmatory safety and efficacy study in ankylosing spondylitis

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2018

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Bio-Thera Solutions
  • Most Recent Events

    • 06 Sep 2018 New trial record
    • 20 Aug 2018 According to a Bio-Thera Solutions media release, the China National Drug Administration (CNDA) has accepted for review the Biologics License Application (BLA) for BAT1406, a proposed biosimilar to Humira (adalimumab), which is used to treat patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. Data from the trial supported the application.
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