An observational, non-interventional, multicenter, prospective study to explore the association of MS-related disability worsening and loss of thalamus volume
- Conditions
- relapsing-remitting multiple sclerosis
- Registration Number
- DRKS00030403
- Lead Sponsor
- jung diagnostics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
? MS, as diagnosed by the revised 2017 McDonald criteria
? Exhibiting a relapsing clinical course and history of brain MRI lesions consistent with MS
? Ages 18 to 55 years, inclusive
? Meet one of the following disease activity criteria
a. more than 10 T2 lesions at the time of the first visit OR
b. at least one documented relapse with the last 12 months prior to the first visit OR
c. documented evidence of at least 1 Gd-enhancing lesion on brain MRI within the last 12 months prior to the first visit OR
d. documented evidence of at least one new or one enlarging T2 lesion within the last 12 months prior to the first visit.
? Either receive or about to receive oral immune therapies as first or second DMT approach, such as teriflunomide, ozanimod, dimethylfumarate, ponesimod, and diroximethylfumarate.
? Either receive or about to receive second line therapies, such as e.g. monoclonal antibodies, but the number of patients receiving monoclonal antibodies should be restricted to 1/3 of the overall study population.
? Primary or secondary progressive MS at time of enrollment
? Patients who are not eligible to receive MRI
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that the change of MS-related disability during a period of 24 months is inversely associated with change of thalamus volume during the same period.
- Secondary Outcome Measures
Name Time Method (S1) To demonstrate that worsening of MS-related disability is associated with loss of thalamus volume when loss of whole brain volume is within the normal range.<br>(S2) To demonstrate that the change of thalamus volume during 24 months is predictive of the change of disability during the following 12 months (months 24-36).