Prospective study to validate a multidimensional treatment decision score (DIFUTURE-MS-TDS) which predicts the 24 month outcome in untreated patients with Clinically Isolated Syndrome and early Relapsing-Remitting Multiple Sclerosis under specific treatment options
- Conditions
- G35.0G35.1G35.9
- Registration Number
- DRKS00014034
- Lead Sponsor
- eurologische Klinik, Klinikum rechts der Isar, TU München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
I 1. Male and female patients between the age of 18 and 60 years with CIS 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
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 baseline)
E 03.Conditions/situations such as:
oPatients 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of the ROC based on the DIFUTURE-MS-TDS score and diseases status at 24 months after start of treatment
- Secondary Outcome Measures
Name Time Method sing a calibration curve to assess calibration for the DIFUTRE-MS-TDS score.<br>Summarizing predictive quality of DIFUTRE-MS-TDS by its Brier Score.<br>Explorative analyses on the predictive relevance of biomarkers for treatment success. Explore predictive value of the DIFUTURE-MS-TDS score on the secondary clinical and paraclinical endpoints.<br>