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A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial Parallel Controlled With Humira to Evaluate the Efficacy and Safety of BAT1406 Injection in the Treatment of Ankylosing Spondylitis

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Trial Profile

A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial Parallel Controlled With Humira to Evaluate the Efficacy and Safety of BAT1406 Injection in the Treatment of Ankylosing Spondylitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2019

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At a glance

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

    • Most Recent Events

    • 07 Nov 2019 According to a Bio-Thera Solutions media release, the China National Medical Products Administration (NMPA) has approved QLETLI for the treatment of three autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.
    • 15 Jun 2019 Primary endpoint has been met. (The proportion of patients achieving ASAS20 response at 12 weeks)
    • 15 Jun 2019 Results assessing safety and immunogenicity of biosimilar BAT1406 vs adalimumab in patients with active active ankylosing spondylitis presented at the 20th Annual Congress of the European League Against Rheumatism
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