A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
NCT Number: NCT06551519
Acronym: FILAXOS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis
Interventions: OTHER: ofatumumab|OTHER: DMT category 1
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2027-08-30

Summary:
This is a prospective, multicenter, observational, non-interventional study (NIS) in patients with Multiple Sclerosis (MS) and routinely assessed serum neurofilament light (sNfL) values in Germany

Primary Outcome Measures: Proportion of patients with high serum neurofilament light (sNfL) levels, Proportion of patients with high serum neurofilament light (sNfL) levels within 24 months of observation, Up to 24 months
Secondary Outcome Measures: sNfL use as a biomarker for Multiple Sclerosis disease activity in clinical practice, Description of perception, utility, frequency of serum neurofilament light (sNfL) measurements and clinical consequences initiated by the treating physician in clinical routine care setting, Up to 24 months|Proportion of patients demonstrating radiological and / or clinical activity, Proportion of patients demonstrating radiological (number of new/enlarging T2 lesions, number of Gadolinium-positive T1 lesions) and / or clinical activity (MS relapse, confirmed disability progression) at Baseline and throughout the study also in context with sNfL level., Up to 24 months|Proportion of patients with no evidence of disease activity (NEDA), Proportion of patients with NEDA at 12 and 24 months as compared to Baseline also in context with sNfL level., Baseline, month 12 and month 24|Proportion of patients demonstrating NEDA 3 and its individual components at 24 months as compared to Baseline, NEDA is defined by no confirmed multiple sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening., Baseline, 24 months|Proportion of patients perceived as clinically stable depending on sNfL level, Proportion of patients perceived as clinically stable depending on sNfL level, Up to 24 months|Multiple sclerosis impact scale 29 (MSIS-29), The Multiple Sclerosis Impact Scale version 2 will be used to assess health-related quality of life. MSIS-29 is a 29-item, self-administered questionnaire that includes two domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day-to-day life., Up to 24 months|Fatigue questionnaire: Fatigue Scale for Motor and Cognitive Functions (FSMC), FSMC consists of 20 items (10 for cognitive fatigue \[FSMCcog\] and 10 for motor fatigue \[FSMCmot\]) with 1-5 points per item. The total possible score ranges from 20-100 points. A sum score of ≥43 is categorized as mild fatigue, ≥53 as moderate fatigue and ≥63 as severe fatigue., Up to 24 months|EuroQol- 5 Dimension (EQ-5D) score, This patient questionnaire is a generic multidimensional measure of health-related quality of life (EuroQol 1990). The five domains of mobility, ability to take care of oneself, everyday activities, pain/discomfort and anxiety/depression are considered. For each dimension, the most appropriate answer is selected from three given possibilities (1=no problem, 2=moderate problem, 3=big problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health)., Up to 24 months|Number of participants using Ekiva MS App, Change in satisfaction scores and evaluation of improvement of patient-physician dialogue and Multiple Sclerosis patient management, Up to 24 months|Treatment Satisfaction Questionnaire for Medication (TSQM) score, The TSQM Version 1.4 comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the subject´s last use. With the exception of item 4 (presence of side effects; yes or no), all items have 5 or 7 responses, scored from 1 (least satisfied) to 5 or 7 (most satisfied). The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow precise information to be obtained at the upper end of the score distribution. Item scores are summarized to give four domain scores, which are in turn transformed to a scale of 0-100., Up to 24 months|Reasons for and proportion of patients switching from current DMTs to ofatumumab, Reasons for and proportion of patients switching from current DMTs to ofatumumab depending on sNfL level, Up to 24 months|Proportion of missed ofatumumab doses within one year,, Proportion of missed ofatumumab doses within one year, defined as the difference between number of planned doses and number of administered doses., Month 12|Proportion of patients who continue to receive their initial treatment, Proportion of patients who continue to receive their initial treatment (ofatumumab or DMT category 1), Month 12 and month 24|Reasons for, number of and duration of treatment interruptions and discontinuations., Reasons for and number of treatment interruptions and discontinuations., Up to 24 months|Duration of treatment interruptions and discontinuations., Duration of treatment interruptions and discontinuations., Up to 24 months|Characterization of patient subgroups with and without 100% adherence, Patients with matching number of planned doses and number of administered doses within 1 year (eg, previous experience with sub-cutaneous therapy), Month 12