G35 G35.1 G35.0
Conditions
Interventions
Group 1: Patients aged 18 – 60 years and diagnosed with CIS or
relapsing remitting MS according to the valid McDonald
20171 diagnostic criteria at the time of diagnosis.
Study subject were be recru
Sponsors
Neurologische Klinik, Klinikum rechts der Isar, TU München
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: I.1 Male and female patients between the age of 18 and 60 years with CIS (meeting the requirements of dissemination in space (but not in time) according to the 2017 McDonald criteria1) or RR-MS according to the valid 2017 McDonald criteria diagnosed within the last two years and before the initiation of immunotherapy. I.2. Having given written informed consent prior to undertaking any study-related procedures.
Exclusion criteria
Exclusion criteria: E.1 Under any administrative or legal supervision or unable to give informed consent. E.2 Previous treatment with disease modifying therapies (DMT; including corticosteroid therapy of relapses if given less than four weeks prior baseline) E.3. Conditions/situations such as: o Patients with conditions/concomitant diseases making them non-evaluable for the primary endpoint (e.g. pre-existing neurological disease, systemic autoimmune diseases) o A requirement for concomitant treatment that could bias primary evaluation o The inability to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the informed consent form) o The patient is directly involved in the conduct of the protocol: the investigator or a subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof o Is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures o Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measures for individual level surrogacy (R², LRF) regarding respective biomarkers and high risk endpoints (NEDA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume and number of new T2-lesions in cMR Imaging during observation time and scheduled examinations. Number of new T2-lesions in sMR Imaging during observation time and scheduled examinations. Disease Progression (EDSS and relapses). Validation of prediction models is based on established measures to quantify discrimination and calibration: AUC, Brier Score, calibration slope and intercept, clinical relevance. Explorative analyses on the predictive relevance of biomarkers for treatment success or disease development. Descriptive analysis of health care service related measures. Evaluation of not yet formulated hypotheses will be of interest. Clinical Outcome after Month 60 & 120. | — |
Countries
Germany
Contacts
Public ContactBernhard Hemmer
Neurologische Klinik, Klinikum rechts der Isar, TU München
Outcome results
None listed