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A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

Trial Profile

A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Sep 2019

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At a glance

  • Drugs Glucocorticoids (Primary) ; Rituximab (Primary)
  • Indications Granulomatosis with polyangiitis; Microscopic polyangiitis
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms PePRS
  • Sponsors Roche
  • Most Recent Events

    • 27 Sep 2019 According to a Genentech media release, on the basis of the results of this study, the company announced that the U.S. Food and Drug Administration (FDA) has approved the company supplemental Biologics License Application (sBLA) for the use of Rituxan (rituximab), in combination with glucocorticoids (GCC), for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older.
    • 12 Jun 2019 According to a Genentech media release, on the basis of the results of this study, the company announced that the U.S. Food and Drug Administration (FDA) has accepted the company supplemental Biologics License Application (sBLA) and granted Priority Review for the use of Rituxan (rituximab), in combination with glucocorticoids (GCC), for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older.
    • 24 Oct 2018 Results presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
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