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A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis

Trial Profile

A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Mar 2019

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Pharmacokinetics
  • Sponsors Roche
  • Most Recent Events

    • 24 Oct 2018 Results presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 21 Sep 2018 According to Roche media release, based on ths data from this study the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the subcutaneous (SC) formulation of RoActemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients one year of age and older.
    • 13 Sep 2018 According to Roche media release, based on ths data from this study the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients two years of age and older.
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