LEM_PASS
Research type
Research Study
Full title
A non-interventional post-authorisation safety study to investigate i) the risk of mortality in multiple sclerosis patients treated with alemtuzumab (Lemtrada®) relative to comparable multiple sclerosis patients using other disease modifying therapies (a cohort study) and ii) drug utilisation and safety monitoring patterns for alemtuzumab
IRAS ID
318741
Contact name
Neil Robertson
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Alemtuzumab (Lemtrada) was approved by the European Medicines Agency (EMA) and NICE for treating multiple sclerosis (MS) in 2014. In 2018, some rare side-effects of alemtuzumab (some of which were fatal) were reported to the EMA for the first time. Therefore in 2019, the EMA requested the company who own alemtuzumab (Sanofi) to conduct two retrospective audit studies.
The first (LEM_PAS_MORT) compares the risk of death in people with MS treated with alemtuzumab compared to people with MS receiving other highly-effective treatments.
The second (LEM_PAS_DUS) investigates drug utilisation and safety monitoring patterns for alemtuzumab following implementation of revisions to the Summary of Product Characteristics. These changes included revisions to indications and contraindications for use, and new safety monitoring recommendations.This is an international study, funded by Sanofi. Within the UK it will examine existing data from patients at 3 sites: Cardiff, Cambridge and Plymouth. These sites were chosen due to their extensive experience of using alemtuzumab in people with MS.
Data will be collected locally at each site from electronic-healthcare records and medical notes which contain all the necessary clinical information. Patients will not be contacted. Relevant data will be entered into the PatientCare electronic health record (a multi-tenant software system) using a pseudonymous identifier. No centre will have access to another centre’s data.
Non-identifiable data will be extracted from PatientCare and transferred to Cardiff University (the lead UK site) for analysis by the Contract Research Organisation (CRO) appointed by Sanofi to undertake this study (iPRI - International Prevention Research Institute, https://i-pri.org). Only aggregated (fully anonymised) summary data will be transferred to iPRI for further analysis with data from other European countries.
REC name
N/A
REC reference
N/A