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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

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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: 25 Jul 2022

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At a glance

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

Most Recent Events

  • 23 Jun 2021 Results assessing safety, tolerability, pharmacokinetics, and efficacy of rituximab in pediatric patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), published in the Arthritis and Rheumatology.
  • 06 Jun 2020 Results presented at the 21st Annual Congress of the European League Against Rheumatism
  • 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.

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