Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)

Condition(s) studied

Investigational drug(s) / intervention(s)

All participants will be asked to provide data and samples for collection and analysis.: During the first year, data related to demographics, lifestyle, clinical examinations will be collected at baseline, at 6 months (optional) and at 12 months. PROs, cognitive and motor assessments will be performed using the Healios+Me smartphone app. Additionally, participants will be asked to provide biological samples (i.e., blood, cerebrospinal fluid and stool, saliva and hair) and imaging data (if performed as per standard of care). One unscheduled visit may be performed in case the participant comes to the hospital with the occurrence of flare or for a treatment change. A long-term follow-up (FU, starting from month 12 and up to 4 years after month 12) is foreseen in this study. During the long-term FU medical data are collected either every 6 month or on a yearly basis, and PROs are collected every 6 months. Whether study visits are conducted in 6- or 12-monthly intervals depends on the schedule of the study visits for the Swiss MS cohort (SMSC).

Study summary

This prospective cohort study is part of the Clinnova programme and aims to (i) identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and with transitioning phases to progressive MS, as well as (ii) to investigate digital biomarkers allowing the continuous clinical monitoring of those patients.

Eligibility

Primary outcome measure(s)

• Set of biomarkers — 2029
  To identify clinical, imaging and omics characteristics associated with early MS and with transitioning phases to progressive MS, a set of biomarkers is derived that allows in the future to better characterize the disease clinical phenotype and progression, the functional impairment of MS patients in different disease stages, and either associated with early MS or with transitioning phase to progressive MS, as an aid to assist clinicians in applying treatment change.

Trial sites (1)

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