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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
Conditions: Multiple Sclerosis
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 519
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Albstadt Baden-Wurttemberg
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.
Source: ClinicalTrials.gov (NCT06551519). StuddyBuddy aggregates publicly available trial information.