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: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

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: 900
Treatment Group(s): 2
Primary Treatment: DMT category 1
Phase:
Study Start date:
October 23, 2024
Estimated Completion Date:
September 16, 2027

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

    Bamberg, Bavaria 96052
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Untermeiting, Bayern 86836
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bad Homburg, Hesse 61348
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Meerbusch, North Rhine-Westfalia 40667
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bad Krozingen, 79189
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bergneustadt, 51702
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 12163
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bielefeld, D 33647
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bogen, 94327
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Duesseldorf, 40211
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Duisburg, 47138
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Essen, 45257
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hamburg, 22179
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Itzehoe, 25524
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Leipzig, 04315
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Muenchen, 81675
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Regensburg, 93059
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Remscheid, 42853
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Salzatal OT Salzmuende, 06198
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Siegen, 57076
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Stuttgart, 70174
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Sundern Hachen, 59846
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Tirschenreuth, 95643
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.