A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

Trial Profile

A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Cladribine (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms CLARITY
  • Sponsors EMD Serono; Merck Serono
  • Most Recent Events

    • 04 Dec 2017 According to an EMD Serono media release, health Canada has approved MAVENCLAD (cladribine tablets) as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability.
    • 28 Oct 2017 Results of post hoc subgroup (patients at higher risk of disease progression) analysis assessing the effects of cladribine 3.5 mg/kg vs placebo presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis
    • 28 Oct 2017 Results of post hoc integrated safety analysis of CLARITY, CLARITY EXTENSION, ORACLE-MS and PREMIERE trials assessing the infectious adverse events occurring during exact periods of Grade 3 or 4 lymphopenia presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis
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