Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)
AttackMS: Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation
Queen Mary University of London
40 participants
Dec 1, 2022
INTERVENTIONAL
Conditions
Summary
Multiple Sclerosis (MS) is a chronic inflammatory \& degenerative disease of the central nervous system (CNS) Recent data from the MS Base registry demonstrated an average delay of 152 - 215 days between first presentation and the diagnosis of MS, and more than one year until Disease Modifying Treatment (DMT) begins. Evidence suggests that shutting down inflammation using highly effective DMTs early after diagnosis leads to better long term clinical outcomes The AttackMS trial will test the effect of starting a highly-effective DMT licensed for MS, Tyruko® (Natalizumab 300mg), within a short time - 14 days - after symptom onset.
Eligibility
Inclusion Criteria5
- Participant has provided informed consent.
- Age 18-55 years
- Participant with CIS or MS at first presentation.
- Participants show two or more lesions on T2 weighted MRI suggestive of demyelination.
- Participant is willing and able to comply with clinical visits and procedures outlined in the study protocol.
Exclusion Criteria16
- Hypersensitivity to Tyruko® or to any of the following excipients:
- Histidine
- Histidine monohydrochloride
- Sodium chloride
- Polysorbate 80 (E433)
- Water for injections
- Evidence of multiple chronic demyelinating lesions on MRI without signs of recent activity.
- Participants with increased risk for opportunistic infections, including immunocompromised participants (those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
- Combination with other Disease Modifying Treatments..
- Known active malignancies, except for participants with cutaneous basal cell carcinoma.
- Implants such as pacemaker, aneurysm clip in the brain and MRI-incompatible prosthetic heart valves.
- Significant comorbidities such as cardiac failure, renal failure, uncontrolled diabetes and uncontrolled hypercholesterolemia.
- History of stroke, thrombosis and/or myocardial infarction.
- Any other infection deemed, in the assessment of the PI or sub-investigator, clinically significant.
- Claustrophobia
- Pregnancy or breastfeeding
Interventions
Tyruko® is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis. Tyruko® 300mg concentrate for solution for infusion and matching placebo are collectively referred to as IMP when detailing to blinded trial procedures. Tyruko® 300mg will be colourless, clear to slightly opalescent solution.
Placebo is colourless, clear to slightly opalescent liquid. The formulation of the is the same as that of commercial Tyruko® minus the active ingredient. Placebo is in the same containers/vials as Tyruko®.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05418010