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

NCT06551519 · tracked via the Priya Life Science Germany tracker

Sponsor

Novartis Pharmaceuticals

Phase

Observational

Started

2024-10-28

Last updated

2026-06-16

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

ofatumumabDMT category 1

ofatumumab: This is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement.

DMT category 1: This is an observational study. There is no treatment allocation. The decision to continue their current DMT will be based solely on clinical judgement.

Study 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

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

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.

Primary outcome measure(s)

Proportion of patients with high serum neurofilament light (sNfL) levels — Up to 24 months
Proportion of patients with high serum neurofilament light (sNfL) levels within 24 months of observation

Trial sites (89)

Facility	City	Region
Novartis Investigative Site	Albstadt	Baden-Wurttemberg
Novartis Investigative Site	Hettingen	Baden-Wurttemberg
Novartis Investigative Site	Mannheim	Baden-Wurttemberg
Novartis Investigative Site	Schwetzingen	Baden-Wurttemberg
Novartis Investigative Site	Bamberg	Bavaria
Novartis Investigative Site	Neuburg A.d. Donau	Bavaria
Novartis Investigative Site	Regensburg	Bavaria
Novartis Investigative Site	Unterhaching	Bavaria
Novartis Investigative Site	Untermeitingen	Bavaria
Novartis Investigative Site	Weiden in Der Oberpfalz	Bavaria
Novartis Investigative Site	Hamburg	Free and Hanseatic City of Hamburg
Novartis Investigative Site	Frankfurt am Main	Hesse
Novartis Investigative Site	Kassel	Hesse
Novartis Investigative Site	Quakenbrück	Lower Saxony
Novartis Investigative Site	Dortmund	North Rhine-Westphalia
Novartis Investigative Site	Dortmund	North Rhine-Westphalia
Novartis Investigative Site	Gelsenkirchen	North Rhine-Westphalia
Novartis Investigative Site	Meerbusch	North Rhine-Westphalia
Novartis Investigative Site	Siegen	North Rhine-Westphalia
Novartis Investigative Site	Sundern Sauerland	North Rhine-Westphalia
Novartis Investigative Site	Chemnitz	Saxony
Novartis Investigative Site	Dresden	Saxony
Novartis Investigative Site	Görlitz	Saxony
Novartis Investigative Site	Leipzig	Saxony
Novartis Investigative Site	Leipzig	Saxony
Novartis Investigative Site	Altenburg	Thuringia
Novartis Investigative Site	Jena	Thuringia
Novartis Investigative Site	Mühlhausen	Thuringia
Novartis Investigative Site	Aalen	Germany
Novartis Investigative Site	Altenholz	Germany
Novartis Investigative Site	Aschaffenburg	Germany
Novartis Investigative Site	Augsburg	Germany
Novartis Investigative Site	Backnang	Germany
Novartis Investigative Site	Bad Krozingen	Germany
Novartis Investigative Site	Bergneustadt	Germany
Novartis Investigative Site	Berlin	Germany
Novartis Investigative Site	Berlin	Germany
Novartis Investigative Site	Berlin	Germany
Novartis Investigative Site	Berlin	Germany
Novartis Investigative Site	Berlin	Germany

+ 49 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting

Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis Active, not recruiting

Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis Recruiting

Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study Enrolling by invitation

Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06551519 on ClinicalTrials.gov ↗ ← All trials in Germany