Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-05-22
700
Participants Needed
109
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light sNfL as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis MS. The study focuses on patients who have received category 1 disease-modifying therapies DMTs and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physicians clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before participation
- Adults aged 18 years or older with relapsing multiple sclerosis
- Treated with EU-approved category 1 disease-modifying therapies for MS according to current guidelines for at least the last 3 months
- Have a serum neurofilament light (sNfL) test result from a commercially available test not older than 3 months
You will not qualify if you...
- Patients treated outside the approved label of their respective disease-modifying therapy
- Simultaneous participation in any interventional study
- Participation in another Novartis-sponsored non-interventional study with ofatumumab
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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