International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

Trial Profile

International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

Completed
Phase of Trial: Phase I

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Infliximab (Primary)
  • Indications Ankylosing spondylitis
  • Focus Pharmacokinetics
  • Acronyms ASART-1
  • Sponsors Biocad
  • Most Recent Events

    • 17 Jun 2017 Results of three clinical trials of infliximab biosimilar BCD-055 (ASART-1, ASART-2 and LIRA) including comparative data on pharmacokinetics (PK), efficacy and safety in a variety of patient populations, presented at the 18th Annual Congress of the European League Against Rheumatism.
    • 03 May 2016 Time frame for primary endpoints has been changed from 28 weeks to 2 weeks.
    • 03 May 2016 Status changed from active, no longer recruiting to completed.
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