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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS

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Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Oct 2021

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At a glance

  • Drugs Cladribine (Primary) ; Interferon beta-1a
  • Indications Multiple sclerosis
  • Focus Therapeutic Use
  • Acronyms ORACLE-MS
  • Sponsors EMD Serono

Most Recent Events

  • 27 Feb 2021 Results (n=923) from CLARITY, CLARITY Extension, and ORACLE-MS trials, and the PREMIERE registry assessing effect of age at baseline in cladribine 3.5 mg/kg on levels of lymphocyte subsets, presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2021
  • 26 May 2020 Results of integrated safety analysis from CLARITY, CLARITY Extension, ORACLE-MS and PREMIERE studies presented at the 6th Congress of the European Academy of Neurology
  • 01 May 2020 Results (n=1564) of integrated pooled analysis from CLARITY, CLARITY Extension, and ORACLE MS trials, and the PREMIERE registry,providing updated safety data of cladribine tablets in the treatment of patients with multiple sclerosis presented at the 72nd Annual Meeting of the American Academy of Neurology

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