Introduction Advances in ultrasensitive assay techniques have enabled precise quantification of serum neurofilament light chain (sNfL) and serum glial fibrillary acidic protein (sGFAP), highlighting their potential as dynamic biomarkers for detecting neuroaxonal injury, disease activity and progression in multiple sclerosis (MS). In the NeuroFilMS study, sNfL is being investigated prospectively as a prognostic biomarker for clinical and radiological disease activity in relapsing MS, while sGFAP is retrospectively explored as a marker of disease progression. The aim is to assess whether longitudinal monitoring of sNfL can inform diagnostic and therapeutic decisions in the treatment of people with MS (pwMS) and whether retrospective sGFAP measurements provide additional insights into disease progression. The study additionally aims to evaluate the comparability of different assay methods. Methods and analysis NeuroFilMS is a prospective, multicentre study that will be conducted across multiple MS study centres throughout Germany, in collaboration with the German Multiple Sclerosis Registry set up by the German National Multiple Sclerosis Society (Deutsche Multiple Sklerose Gesellschaft). The study aims to enrol 1500 pwMS diagnosed with relapsing MS.
Introduction Advances in ultrasensitive assay techniques have enabled precise quantification of serum neurofilament light chain (sNfL) and serum glial fibrillary acidic protein (sGFAP), highlighting their potential as dynamic biomarkers for detecting neuroaxonal injury, disease activity and progression in multiple sclerosis (MS). In the NeuroFilMS study, sNfL is being investigated prospectively as a prognostic biomarker for clinical and radiological disease activity in relapsing MS, while sGFAP is retrospectively explored as a marker of disease progression. The aim is to assess whether longitudinal monitoring of sNfL can inform diagnostic and therapeutic decisions in the treatment of people with MS (pwMS) and whether retrospective sGFAP measurements provide additional insights into disease progression. The study additionally aims to evaluate the comparability of different assay methods. Methods and analysis NeuroFilMS is a prospective, multicentre study that will be conducted across multiple MS study centres throughout Germany, in collaboration with the German Multiple Sclerosis Registry set up by the German National Multiple Sclerosis Society (Deutsche Multiple Sklerose Gesellschaft). The study aims to enrol 1500 pwMS diagnosed with relapsing MS. Participants will be randomised in a 2:1 ratio (n=1000 vs n=500) to either immediate sNfL reporting or delayed sNfL reporting to treating physicians, in order to evaluate how sNfL availability influences therapeutic decision-making in routine healthcare regarding diagnostics and therapy decisions. Over a 2-year follow-up period, pwMS will attend three study visits integrated into routine care, including blood sampling for sNfL, clinical evaluations and routine MRI assessments; sGFAP will be measured retrospectively in batches, as it is not currently available for routine diagnostic use. The study follows the standardised protocols for biosample collection, performed both within clinical routine laboratory procedures and through research collaboration. Statistical analyses will involve both descriptive and inferential methods to evaluate biomarker performance and clinical associations. Ethics and dissemination The study has received ethical approval from the Clinical Ethics Committee of Charité - Universitätsmedizin Berlin (EA4/136/24) and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Findings will be disseminated through peer-reviewed publications, conference presentations and engagement with patient organisations and clinical networks. Trial registration number DRKS00034337.