NCT06551519 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 ID | NCT06551519 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2028-11-29 |
Trial Parameters
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Brief 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 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.
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