Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Trials

Trial Profile

Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Trials

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2017

At a glance

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

    • 25 Aug 2017 According to a Merck & Co media release, based on the data from three Phase III trials (CLARITY, CLARITY EXTENSION and ORACLE MS) and a phase II trial (ONWARD) including long term data from PREMIERE study, the European Commission (EC) has granted marketing authorization for MAVENCLAD 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis (RMS) in the 28 countries of the European Union (EU).
    • 09 Aug 2017 Status changed from recruiting to active, no longer recruiting.
    • 27 Jun 2017 Results assessing the absolute lymphocyte count in patients treated with cladribine 3.5mg/kg using pooled data (n=685) from CLARITY and CLARITY Extension and PREMIERE registry along with data from patients randomised to placebo (n=435) in CLARITY and followed up in CLARITY Extension and PREMIERE, presented at the 3rd Congress of the European Academy of Neurology.
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