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Evaluating serum neurofilament as a marker for managing 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)

Observational Novartis · NCT06551519

This study is testing if measuring a specific protein in the blood can help doctors make better treatment choices for people with relapsing multiple sclerosis.

Quick facts

Study typeObservational
Enrollment700 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsofatumumab
Locations109 sites (Albstadt, Baden-Wurttemberg and 108 other locations)
Trial IDNCT06551519 on ClinicalTrials.gov

What this trial studies

This observational study collects primary data from patients with relapsing multiple sclerosis (MS) in Germany, focusing on serum neurofilament light (sNfL) values. Participants, who have been treated with category 1 disease-modifying therapies (DMTs), will either continue their current treatment or switch to ofatumumab based on their physician's discretion. Data will be gathered over a maximum period of 24 months, following routine clinical care and monitoring procedures. The study aims to assess the clinical utility of sNfL in guiding treatment decisions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with relapsing multiple sclerosis who have been on category 1 DMTs and have recent sNfL test results.

Not a fit: Patients receiving treatment outside the approved label of their DMT or participating in other interventional studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance patient management by providing a reliable prognostic marker for disease activity in MS.

How similar studies have performed: While the use of serum neurofilament as a prognostic marker is gaining attention, this specific approach in the context of MS management is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants eligible for inclusion in this study must meet all the following criteria:

1. Written informed consent must be obtained before participation in the study.
2. RMS patients aged 18 or older.
3. 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.
4. Presence of a sNfL test result from a commercially available test not older than 3 months.

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study:

1. Patients being treated outside of the approved label of the respective DMT.
2. Simultaneous participation in any interventional study or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab.

Where this trial is running

Albstadt, Baden-Wurttemberg and 108 other locations

+59 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple SclerosisMultiple sclerosisMSOfatumumabNISGermany
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.