MultiSCRIPT â€“ Personalized medicine in Multiple Sclerosis
A pragmatic platform trial within the Swiss MS Cohort

An innovative approach to patient care

…  to optimize therapies over the long term to treat patients as little as possible but as much as necessary at the right time.

A learning system

… of sequential pragmatic randomized trials fully embedded in patients’ usual care within the Swiss Multiple Sclerosis Cohort (SMSC).

Pragmatic trials

… merging scientific rigor of randomized trials with the advantages of real-world data to inform decision-making in routine care.

Swiss MS cohort

… offers a unique opportunity to establish a platform trial to continuously assess multiple new interventions

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

4

(updated: 06/09/24)

Participants

373

(updated: 06/09/24)

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