relapsing-remitting multiple sclerosis
Conditions
Interventions
Group 1: EDSS status will be collected at least annually from participating patients, with additional optional SDMT status collected at least annually.
Sponsors
jung diagnostics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: ? Primary or secondary progressive MS at time of enrollment ? Patients who are not eligible to receive MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| (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. (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). (S3) To demonstrate that the change of MS-related disability during a period of 24 months is inversely associated with change of whole brain volume during the same period. (S4) To confirm that Biometrica MS, which calculates change of whole brain and thalamic volume using an AI powered algorithm, differentiates patients with and without worsening of MS-related disability for a follow-up period of 12 and 24 months. | — |
Countries
Germany
Contacts
Public ContactLothar Spies
jung diagnostics GmbH
Outcome results
None listed