A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis

Trial Profile

A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Mar 2017

At a glance

  • Drugs Daclizumab (Primary) ; Caffeine; Dextromethorphan; Midazolam; Omeprazole; Vitamin K; Warfarin
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms OBSERVE
  • Sponsors Biogen
  • Most Recent Events

    • 19 Mar 2016 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
    • 17 Mar 2016 Results (n=20) published in the British Journal of Clinical Pharmacology.
    • 28 Jan 2016 Planned End Date changed from 1 Jan 2017 to 1 Feb 2016 as per ClinicalTrials.gov record.
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