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

Last updated: June 12, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Memory Loss

Multiple Sclerosis

Scar Tissue

Treatment

DMT category 1

ofatumumab

Clinical Study ID

NCT06551519
COMB157GDE04
  • Ages 18-99
  • All Genders

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 Criteria

Inclusion

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 currentguidelines (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 3months.

Exclusion

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 participationin another Novartis-sponsored non-interventional study with ofatumumab.

Study Design

Total Participants: 489
Treatment Group(s): 2
Primary Treatment: DMT category 1
Phase:
Study Start date:
October 28, 2024
Estimated Completion Date:
November 29, 2028

Study 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 of 24 months.

The observational period will not be dictated by the protocol. Baseline and follow-up visits will take place at a frequency defined as per Investigator´s discretion following clinical routine. The diagnostic or monitoring procedures are only those ordinarily applied to therapeutic strategy and routine clinical care. During the observation phase of the study, data will be collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).

Eligible participants for the study are patients who have received treatment with category 1 DMTs and those who have included sNfL into their treatment decision-making process. These patients have the option to either continue their current DMT or switch to ofatumumab. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide. The decision to switch to ofatumumab or to continue the current DMT category 1 therapy must be made by the treating physician independently of the decision to enroll the patient in the study.

Connect with a study center

  • Novartis Investigative Site

    Albstadt, Baden-Wurttemberg 72458
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hettingen, Baden-Wurttemberg 72513
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg 68163
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schwetzingen, Baden-Wurttemberg 68723
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bamberg, Bavaria 96052
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuburg A.d. Donau, Bavaria 86633
    Germany

    Site Not Available

  • Novartis Investigative Site

    Regensburg, Bavaria 93059
    Germany

    Site Not Available

  • Novartis Investigative Site

    Unterhaching, Bavaria 82008
    Germany

    Site Not Available

  • Novartis Investigative Site

    Untermeitingen, Bavaria 86836
    Germany

    Site Not Available

  • Novartis Investigative Site

    Weiden in Der Oberpfalz, Bavaria 92637
    Germany

    Site Not Available

  • Novartis Investigative Site

    Untermeiting, Bayern 86836
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg 22297
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt am Main, Hesse 65929
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kassel, Hesse 34121
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt am Main 2925533, Hesse 2905330 60311
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Quakenbrück, Lower Saxony 49610
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia 44135
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gelsenkirchen, North Rhine-Westphalia 45894
    Germany

    Site Not Available

  • Novartis Investigative Site

    Meerbusch, North Rhine-Westphalia 40667
    Germany

    Site Not Available

  • Novartis Investigative Site

    Siegen, North Rhine-Westphalia 57072
    Germany

    Site Not Available

  • Novartis Investigative Site

    Sundern Sauerland, North Rhine-Westphalia 59846
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dortmund 2935517, North Rhine-Westphalia 2861876 44287
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Siegen 2832495, North Rhine-Westphalia 2861876 57072
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dresden, Saxony 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Görlitz, Saxony 02828
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, Saxony 04315
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig 2879139, Saxony 2842566 04299
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Altenburg, Thuringia 04600
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena, Thuringia 07740
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mühlhausen, Thuringia 99974
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aalen, 73433
    Germany

    Site Not Available

  • Novartis Investigative Site

    Altenholz, 24161
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Novartis Investigative Site

    Augsburg, 86150
    Germany

    Site Not Available

  • Novartis Investigative Site

    Backnang, 71522
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Krozingen, 79189
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bergneustadt, 51702
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 12163
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin 2950159, 12163
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bielefeld, 33647
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44787
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bogen, 94327
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bonn, 53111
    Germany

    Site Not Available

  • Novartis Investigative Site

    Chemnitz, 09117
    Germany

    Site Not Available

  • Novartis Investigative Site

    Coburg, 96450
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dessau, 06846
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dierdorf, 56269
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dillingen Saar, 66763
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden 2935022, 01067
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Duisburg, 47138
    Germany

    Site Not Available

  • Novartis Investigative Site

    Düsseldorf, 40211
    Germany

    Site Not Available

  • Novartis Investigative Site

    Düsseldorf 2934246, 40211
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Eisleben Lutherstadt, 06295
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erbach im Odenwald, 64711
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erfurt, 99096
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45138
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen 2928810, 45138
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Gelsenkirchen 2921466, 45894
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Gera, 07548
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hagen, 58099
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg 2911298, 22179
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Heidenheim, 89518
    Germany

    Site Not Available

  • Novartis Investigative Site

    Herford, 32049
    Germany

    Site Not Available

  • Novartis Investigative Site

    Höxter, 37671
    Germany

    Site Not Available

  • Novartis Investigative Site

    Itzehoe, 25524
    Germany

    Site Not Available

  • Novartis Investigative Site

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Novartis Investigative Site

    Katzenelnbogen, 56368
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg, 39120
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Magdeburg 2874545, 39120
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Merzig, 66663
    Germany

    Site Not Available

  • Novartis Investigative Site

    Minden, 32423
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 80939
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    München, 80939
    Germany

    Site Not Available

  • Novartis Investigative Site

    München 2867711, 80939
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Münster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuwied, 56564
    Germany

    Site Not Available

  • Novartis Investigative Site

    Osnabrück, 49074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Pforzheim, 75172
    Germany

    Site Not Available

  • Novartis Investigative Site

    Remscheid, 42853
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rülzheim, 76761
    Germany

    Site Not Available

  • Novartis Investigative Site

    Salzatal, 06198
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schwäbisch Hall, 74523
    Germany

    Site Not Available

  • Novartis Investigative Site

    Singen, 78224
    Germany

    Site Not Available

  • Novartis Investigative Site

    Sinsheim, 74889
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stuttgart, 70174
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stuttgart 2825297, 70174
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Tirschenreuth, 95643
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89073
    Germany

    Site Not Available

  • Novartis Investigative Site

    Velbert, 42551
    Germany

    Site Not Available

  • Novartis Investigative Site

    Weil der Stadt, 71263
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wolfenbüttel, 38300
    Germany

    Site Not Available

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