DELIVER MS
Research type
Research Study
Full title
Determining the Effectiveness of early Intensive Versus Escalation approaches for the treatment of Relapsing-Remitting Multiple Sclerosis (DELIVER-MS)
IRAS ID
243333
Contact name
Nikos Evangelou
Contact email
Sponsor organisation
Nottingham University NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
DELIVER-MS seeks to answer an important question: Does early treatment with Disease Modifying Treatment(s) (DMTs) improve prognosis for people with MS? This is an area of controversy and no scientific data exists to guide treatment choices for patients and clinicians.
The study tests two treatment approaches
1. An Escalation Approach (EA)
A person with MS and their neurologist decide to start using a safer but moderately effective medication monitored through regular clinic appointments and MRI scans. Should any breakthrough MS activity (e.g. relapses, new brain lesions) occur, they are escalated to more powerful medications, with somewhat higher risks.
2. An Early Highly Effective Treatment (EHT) approach
A person with MS and their neurologist decide to start using a stronger but potentially riskier DMT, monitored at clinical appointments and through MRI scans.
The study is a ‘Randomised Clinical Trial (RCT) happening in centers for MS in the US and UK. After assessing if people are eligible to take part, we will ‘randomly’ allocate them to either the EA or EHT treatment approach and then compare their results. We will also compare them to the same number of randomly selected people who do not receive either option, as a ‘control’. These are known as the ‘additional parallel observational cohort’ or ‘group’. An RCT such as this is often considered the gold standard for a medical research trial, testing how well various types of medical approaches work. It can also provide information about adverse effects, such as drug reactions.
This study is also ‘pragmatic’, conducted in conditions representative of the real world, providing high quality evidence, enabling decisions to be made that can improve the health of specific subgroups and of the population as a whole.REC name
Wales REC 2
REC reference
18/WA/0239
Date of REC Opinion
3 Aug 2018
REC opinion
Further Information Favourable Opinion