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A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody

Trial Profile

A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Jun 2022

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At a glance

  • Drugs Rituximab (Primary)
  • Indications Neuromyelitis optica; Optic neuritis
  • Focus Registrational; Therapeutic Use
  • Acronyms RIN-1
  • Sponsors Zenyaku Kogyo
  • Most Recent Events

    • 20 Jun 2022 According to a Chugai Pharmaceutical media release, this study was conducted at eight hospitals in Japan lead by Dr. Oeda and Dr. Sawada, and was funded by the Japan Agency for Medical Research and Development.
    • 20 Jun 2022 According to a Chugai Pharmaceutical media release, based on results from this study the Zenyaku obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), for an anti-CD20 monoclonal antibody Rituxan intravenous injection 100 mg and 500 mg for the prevention of recurrence of neuromyelitis optica spectrum disorder (including neuromyelitis optica).
    • 26 Feb 2022 Results presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2022
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