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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 Polyarticular Juvenile Idiopathic Arthritis

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Pharmacokinetics
  • Acronyms JIGSAW 117
  • Sponsors Roche

    • Most Recent Events

    • 28 Jan 2021 Results of two clinical trials in children with systemic juvenile idiopathic arthritis (n=51; NCT01904292) and polyarticular juvenile idiopathic arthritis (n=52; NCT01904279) conducted to identify optimal dosing regimens of subcutaneous tocilizumab published in the Rheumatology.
    • 15 Jun 2019 Trial has been completed in UK, according to European Clinical Trials Database record.
    • 14 May 2018 The U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older. The approval is based on data from this trial, as reported in a Genentech media release.

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