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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History