RecruitingN/ADMT

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

Sponsored by Novartis Pharmaceuticals

NCT ID
NCT06551519
Target Enrollment
700 participants
Start Date
2024-10-28
Est. Completion
2028-11-29

About This Study

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

Conditions Studied

Multiple Sclerosis

Interventions

  • ofatumumab
  • DMT category 1

Eligibility

Age:18 Years - 99 Years
Healthy Volunteers:No
View full 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.

Study Locations (109)

Novartis Investigative Site
Albstadt, Baden-Wurttemberg, Germany
Novartis Investigative Site
Hettingen, Baden-Wurttemberg, Germany
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany
Novartis Investigative Site
Schwetzingen, Baden-Wurttemberg, Germany
Novartis Investigative Site
Bamberg, Bavaria, Germany
Novartis Investigative Site
Neuburg A.d. Donau, Bavaria, Germany
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Unterhaching, Bavaria, Germany
Novartis Investigative Site
Untermeitingen, Bavaria, Germany
Novartis Investigative Site
Weiden in Der Oberpfalz, Bavaria, Germany

+99 more locations

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Novartis Pharmaceuticals
CONTACT
+41613241111novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source