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A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

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Trial Profile

A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Rituximab (Primary) ; Glucocorticoids; Mycophenolate mofetil
  • Indications Pemphigus vulgaris
  • Focus Registrational; Therapeutic Use
  • Acronyms PEMPHIX
  • Sponsors Roche

Most Recent Events

  • 20 May 2021 Results evaluating patient-reported outcomes in PEMPHIX presented at the 26th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
  • 19 May 2021 Before the results were unblinded, the protocol and statistical analysis plan were amended to include the scores on the Patient Global Impression of Change and the Clinician Global Impression of Change scales as exploratory end-point measures and not as secondary end points
  • 19 May 2021 Results published in the New England Journal of Medicine

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