Study identification

EU PAS number

EUPAS44059

Study ID

44060

Official title and acronym

OPTIMISE:MS A Prospective, Real World Pharmacovigilance Study in Multiple Sclerosis

DARWIN EU® study

No

Study countries

United Kingdom

Study description

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.

Study status

Ongoing
Research institutions and networks

Institutions

Imperial College London
United Kingdom
First published:
01/02/2024
Institution Educational Institution
Royal London Hospital London, John Radcliffe Hospital Oxford, Frimley Park Hospital Surrey, Nottingham University Hospitals NHS Trust Nottingham, Salford Royal NHS Foundation Trust Great Manchester, Greater Glasgow and Clyde Scotland, Plymouth Hospital NHS Trust Plymouth, Southend University Hospital NHS Foundation Trust Essex, St Georges Hospital London, University Hospitals Bristol NHS Foundation Trust Bristol

Contact details

Aleisha Miller

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Other

More details on funding

Biogen, Merck, Bristol Myers Squibbs
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable