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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

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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 Systemic 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 JIGSAW118
  • 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.
  • 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.

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