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: 14 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

    • 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.
    • 23 Jun 2017 According to a Merck & Co media release, the CHMP's recommendation will be referred to the European Commission which is expected to make a final decision on the marketing authorisation application for Cladribine Tablets within 67 days from the CHMP opinion.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top