A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)

Trial Profile

A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Oct 2017

At a glance

  • Drugs Cladribine (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions
  • Acronyms CLARITY EXTENSION
  • Sponsors EMD Serono
  • Most Recent Events

    • 28 Oct 2017 Results assessing the effect of cladribine on on B and T lymphocyte and NK cell in the ORACLE-MS, CLARITY and CLARITY Extension studies, 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
    • 28 Oct 2017 Results of analysis assessing effect of cladribine 3.5 mg/kg on innate immune cell count using patient data pooled from CLARITY and CLARITY Extension trials 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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