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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 May 2020

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At a glance

  • Drugs Eculizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGAIN
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 26 May 2020 Results of infection rates with or without concomitant PREVENT, REGAIN and respective open-label extensions immunosuppressant therapy (IST) in presented at the 6th Congress of the European Academy of Neurology
    • 01 May 2020 Results of post-hoc pooled analysis of infection risk in patients receiving eculizumab in 4 studies (PREVENT (NCT01892345), REGAIN (NCT01997229), NCT02003144 and NCT02301624), presented at the 72nd Annual Meeting of the American Academy of Neurology.
    • 26 Dec 2017 According to an Alexion Pharmaceuticals media release, the Ministry of Health, Labour and Welfare (MHLW) of Japan in December 2017 approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).
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