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
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 (FILAXOS)
Novartis Pharmaceuticals
700 participants
Oct 28, 2024
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- Participants eligible for inclusion in this study must meet all the following criteria:
- Written informed consent must be obtained before participation in the study.
- RMS patients aged 18 or older.
- Treated in label with EU-approved DMTs for MS category 1 according to current guidelines (Hemmer et al 2023) for at least the last 3 months.
- Presence of a sNfL test result from a commercially available test not older than 3 months.
Exclusion Criteria3
- Participants meeting any of the following criteria are not eligible for inclusion in this study:
- Patients being treated outside of the approved label of the respective DMT.
- Simultaneous participation in any interventional study or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab.
Interventions
This is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement.
This is an observational study. There is no treatment allocation. The decision to continue their current DMT will be based solely on clinical judgement.
Locations(108)
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NCT06551519