Post authorisation observational study of Lemtrada in MS patients
Research type
Research Study
Full title
A PROSPECTIVE, MULTICENTER, OBSERVATIONAL POST-AUTHORIZATION SAFETY STUDY TO EVALUATE THE LONG TERM SAFETY PROFILE OF LEMTRADA® (ALEMTUZUMAB) TREATMENT IN PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
IRAS ID
182056
Contact name
Jeremy Hobart
Contact email
Sponsor organisation
Genzyme, a Sanofi Company
Duration of Study in the UK
13 years, 5 months, 0 days
Research summary
This is a multi-centre, post authorisation, observational study to evaluate the long term safety profile of LEMTRADA (alemtuzumab) treatment in patients wil relapsing forms of multiple sclerosis (RMS).
This is an observational study with no experimental intervention utilized. Enrolled patients will receive treatment and evaluations for their MS as determined by their treating physicians in accordance with local standard of care. Visits will be scheduled by the treating healthcare provider (HCP) according to patient-specific needs and local clinical practice. For purposes of this study, HCPs will be requested to record information on enrolled patients at the time of study enrolment, and then to conduct follow-up data entry on a semi-annual basis for a period of 5 years post-enrolment.
The full study duration is expected to be approximately 9 years, including an approximate 4 year enrolment period.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
15/YH/0276
Date of REC Opinion
10 Jun 2015
REC opinion
Favourable Opinion