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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44060
• 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

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

Study timelines

Date when funding contract was signed

Planned: 25/07/2018

Actual: 25/07/2018

Study start date

Planned: 28/04/2019

Actual: 28/04/2019

Data analysis start date

Planned: 27/08/2019

Actual: 27/08/2019

Date of final study report

Planned: 12/12/2026

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Biogen, Merck, Bristol Myers Squibbs

Study protocol

Initial protocol

OPTIMISE_PROTOCOL_v6.0_12_APR_2021_CLEAN

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

IRAS: 252793