Status:
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-99 years
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
Detailed Description
Prospective, primary data will be collected from patients with sNfL outcomes in the context of switching to ofatumumab or continuing their current therapy. Data collection will cover a maximum period ...
Eligibility Criteria
Inclusion
- Participants eligible for inclusion in this study must meet all the following criteria:
- Written informed consent must be obtained before participation in the study.
- RMS patients aged 18 or older.
- 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.
- Presence of a sNfL test result from a commercially available test not older than 3 months.
Exclusion
- Participants meeting any of the following criteria are not eligible for inclusion in this study:
- Patients being treated outside of the approved label of the respective DMT.
- Simultaneous participation in any interventional study or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab.
Key Trial Info
Start Date :
October 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 29 2028
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06551519
Start Date
October 23 2024
End Date
November 29 2028
Last Update
December 30 2025
Active Locations (104)
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1
Novartis Investigative Site
Albstadt, Baden-Wurttemberg, Germany, 72458
2
Novartis Investigative Site
Hettingen, Baden-Wurttemberg, Germany, 72513
3
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany, 66163
4
Novartis Investigative Site
Schwetzingen, Baden-Wurttemberg, Germany, 68723