MS real-world pharmacovigilance study
Research type
Research Study
Full title
A prospective, real world pharmacovigilance study in Multiple Sclerosis
IRAS ID
252793
Contact name
Paul Matthews
Contact email
Sponsor organisation
Imperial College Joint Research Compliance Office
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
This pragmatic, prospective observational cohort study is planned to run for 7 years to estimate the frequency of serious adverse events with real world DMT use in routine clinical practice in the UK. It is a non-interventional cohort study. The study will recruit people with MS on treatment from major MS care clinics across the country, as well as those starting, switching or potentially eligible for treatment, but who are not currently taking DMT. This study will provide – for the first time - an estimate of overall rates of serious adverse events associated with DMT (including multiple sclerosis relapses or opportunistic infections) in the UK population with MS. It will facilitate a way of exploring related questions regarding the relative benefits vs risks of treatment and the influence of prior treatments on adverse events.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0064
Date of REC Opinion
15 Jan 2019
REC opinion
Favourable Opinion