MultiSCRIPT - Treatment Optimization in Multiple Sclerosis
This study establishes a trial platform that continuously evaluates novel personalised treatments for multiple sclerosis (MS) compared to standard care. For this purpose, an interdisciplinary team from the Neurological Clinic and Polyclinic, the MS Center and the RC2NB at the University Hospital Basel is building a learning system of sequential pragmatic randomised trials fully embedded in routine patient care within the Swiss Multiple Sclerosis Cohort (SMSC).
The treatment of MS requires a high level of individualised care and personalised therapeutic approaches. This project aims to generate evidence on how to treat MS patients as little as possible, but as much as necessary and at the appropriate time. Timely and accurate detection of signs of disease activity is crucial to better guide therapy and enable optimised decision making together with the affected person.
Background
Intensive and precise monitoring of treatment response in MS could help avoid over- or under-treatment and thus to minimise side effects as well as the corresponding costs while achieving optimal effect. In addition, the number of magnetic resonance imaging (MRI) scans currently used to detect disease activity could be reduced in the future.
Objective
This study investigates how intensive monitoring of biomarkers can improve patient-relevant outcomes as well as the care of MS patients.
MultiSCRIPT Study
Personalized medicine in MULTIple SClerosis, a pRagmatIc Platform Trial embedded within SMSC
Principle Investigators
Prof. Özgür Yaldizli, MD, (USB), PI
PD Dr. Lars G.Hemkens (DKF), CO-PI
Prof. Jens Kuhle (USB), CO-PI
Prof. Chiara Zecca (EOC), CO-PI
Study Design
Pragmatic multicenter 1:1 randomized-controlled parallel group, superiority, platform study embedded in the
Swiss Multiple Sclerosis Cohort (SMSC)
Study sites
8
Number of planned study participants
tbd
Project duration
2022-2025
DKF support
Methodological Consulting, Consulting for Patient and Public Involvement (PPI), Statistics, Regulatory Affairs, Project Management, Data Management, Data Science, Monitoring
Funding
SNF IICT
How can treatment options in MS be efficiently compared and continuously improved?
Study methodology
Pragmatic multicenter 1:1 randomised-controlled parallel group, superiority, platform study, embedded in the Swiss Multiple Sclerosis Cohort (SMSC)
Significance of the study
The potentially achievable treatment optimisations through this study may lead to cost reductions for the health care system on the one hand, but also to an improvement in the quality of life for patients on the other hand. Finally, monitoring of the NfL values, which is associated with little effort, may provide additional safety for both treatment providers and patients.
July 2022