MultiSCRIPT – Personalized medicine in Multiple Sclerosis
A pragmatic platform trial within the Swiss MS Cohort
Cycle 1 – intensive disease monitoring using a neurofilament biomarker
Principal investigator – Prof Özgür Yaldizli, University Hospital Basel
Multiple sclerosis (MS) is a chronic and disabling disease where the immune system attacks the nervous system. The most common type is relapsing-remitting MS (RRMS), which is managed with disease modifying therapies. Such therapies reduce the inflammatory activity by weakening the immune system. However, such weakening may cause undesirable side effects.
It is therefore important to treat person with MS as little as possible but as much as necessary at the right time. Unfortunately, “tailor-made” treatment strategies for each individual do not currently exist. This could be achieved with regular measurements of nerve components in the blood, so-called neurofilaments. Neurofilaments indicate very precisely the damage to nerve cells caused by the disease and thus indicating disease activity. Intensive disease montioring of neurofilaments may be instrumental in personalized treatment adaptations.
Protocol avaible as a preprint on MedRxiv
RECRUITING
TRIAL STATUS
Ongoing
active sites
7
(updated: 04/12/24)
Participants
552
(updated: 04/12/24)
Design: pragmatic randomized trial
Participants: SMSC participants with relapsing-remitting MS
Planned sample size: 915 participants
Setting: SMSC usual care
Comparison: 6-monthly biomarker monitoring strategy using sNfL versus SMSC usual care
Primary outcomes: 1) Evidence of disease activity and 2) Quality of life
Duration: minimum 1.5 years to maximum 3.5 years for participants
Sponsor: University Hospital Basel
Funder: Swiss National Science Foundation (grant number-205806)
Registration: NCT06095271