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: 30 Jul 2018

At a glance

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

    • 30 Jul 2018 According to a Merck KGaA 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 US FDA has accepted the New Drug Application (NDA) for cladribine tablets, after the resubmission of an application, as a potential treatment for patients with relapsing forms of multiple sclerosis (MS).
    • 30 Jul 2018 Argentina, Australia, Belize, Bosnia-Herzegovina, Brazil, Canada, Croatia, Georgia, India, Lebanon, Macedonia, Morocco, Netherlands, Norway, Romania, Russia, Saudi Arabia, South Korea, Serbia, Singapore, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, Ukraine were the planned locations for this study.
    • 19 Jun 2018 Results of a post-hoc analysis from CLARITY, CLARITY-Extension, ORACLE-MS and PREMIERE, trials presented at the 4th Congress of the European Academy of Neurology
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