AttackMS
Research type
Research Study
Full title
AttackMS - Natalizumab for the treatment of people with inflammatory demyelination suggestive of multiple sclerosis, or definite multiple sclerosis, at first presentation
IRAS ID
1003822
Contact name
Klaus Schmierer
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2021-002255-11
Clinicaltrials.gov Identifier
Research summary
MS is a disease of the central nervous system affecting over 130,000 people in the UK and more than 2.8 million worldwide. We do not yet know why someone develops MS. However, left untreated, MS leads to chronic disability in the large majority of cases.
CIS is a common first manifestation of MS: There is a more than 80% chance of MS in somebody presenting with CIS provided one or more “lesions” characteristic of inflammatory demyelination can be detected on a magnetic resonance imaging (MRI) of the brain. The presence of at least two such lesions is an inclusion criterion for this study. Inflammatory demyelination is the process by which cells of your body’s own immune system attack the insulation sheath (= myelin) of nerve fibres (= axons) in the central nervous system.
Once a diagnosis of MS has been confirmed, many people with this disease will be eligible for what is called “disease-modifying treatment” (DMT) on the NHS. Such treatment targets the immune cells that are involved in the inflammatory attack against the myelin sheaths and nerve fibres. However, whilst in a small number of cases, a diagnosis of MS can be made instantaneously, it regularly takes week, months and sometimes even longer, to fulfil the formal diagnostic criteria of MS. This diagnostic delay inevitably leads to delays in starting disease-modifying treatment (DMTs).
Using a trial concept geared towards rapid assessment of eligibility, and a disease modifying treatment (DMT) that is both highly effective and generally well tolerated in people with MS, AttackMS will test whether:
(i) It is feasible to recruit participants with a diagnosis of CIS at high risk of MS, or definite MS, at first presentation for treatment within 14 days of symptom onset and
(ii) Such early treatment improves myelin repair at 3 months, as measured using a special MRI technology called magnetisation transfer ratio (MTR).REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0043
Date of REC Opinion
3 Mar 2022
REC opinion
Further Information Favourable Opinion