G35
Conditions
Interventions
Group 1: The prospective study will focus on newly diagnosed treatment naïve MS patients and involve deep phenotypic characterization of the cohort over 24 months including brain and spinal cord magne
Sponsors
Klinikum Rechts der Isar
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Male and female patients between the age of 18 and 50 years with CIS (meeting the requirements of dissemination in space) or MS (both relapsing remitting and primary progressive) according to the valid McDonald criteria diagnosed within the last two years and before the initiation of immunotherapy. Corticosteroid therapy for treatment of relapses is allowed if the treatment was stopped at least 4 weeks before inclusion in the study. Having given written informed consent prior to undertaking any study-related procedures. (not applicable for retrospective studies) Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
Exclusion criteria
Exclusion criteria: Patients who have met all the above inclusion criteria will be screened for the following exclusion criteria: E 01. Under any administrative or legal supervision or unable to give informed consent. E 02. Previous treatment with DMT drugs (including corticosteroid therapy of relapses if given less than four weeks prior inclusion) E 03. Conditions/situations such as: • Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint (e.g. pre-existing neurological disease, systemic autoimmune diseases) • A requirement for concomitant treatment that could bias primary evaluation • An impossibility to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the protocol) • The patient is the Investigator or a subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol • Is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures • Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate the MultipleMS risk score (emerging from the combined analysis of existing clinical, paraclinical, environmental, multiOmics and biomarker data) to predict the course in early MS and clinically isolated syndrome (CIS) patients determined by magnetic resonance imaging (MRI) of the brain and spinal cord | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the predictive value of the Multiple MS risk score on clinical, MRI and other endpoints | — |
Countries
Belgium, Denmark, Germany, Italy, Norway, Spain, Sweden
Contacts
Public ContactBernhard Hemmer
Klinikum Rechts der Isar
Outcome results
None listed