MedDataX Logo

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

NCT ID: NCT06551519

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-23

Study Completion Date

2028-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Multiple sclerosis MS Ofatumumab NIS Germany

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ofatumumab

Patients who have received treatment with category 1 DMTs and decided to switch to ofatumumab

ofatumumab

Intervention Type OTHER

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

Category 1 DMTs

Patients who continued with DMT category 1 treatment. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide.

DMT category 1

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ofatumumab

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Albstadt, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Hettingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Schwetzingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Bamberg, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Neuburg an der Donau, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Untermeiting, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Hamburg, Hamburg, Germany

Site Status RECRUITING

Novartis Investigative Site

Bad Homburg, Hesse, Germany

Site Status RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Novartis Investigative Site

Kassel, Hesse, Germany

Site Status RECRUITING

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, Germany

Site Status RECRUITING

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, Germany

Site Status RECRUITING

Novartis Investigative Site

Meerbusch, North Rhine-Westphalia, Germany

Site Status RECRUITING

Novartis Investigative Site

Siegen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Novartis Investigative Site

Dresden, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Görlitz, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Leipzig, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Leipzig, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Altenburg, Thuringia, Germany

Site Status RECRUITING

Novartis Investigative Site

Jena, Thuringia, Germany

Site Status RECRUITING

Novartis Investigative Site

Mühlhausen, Thuringia, Germany

Site Status RECRUITING

Novartis Investigative Site

Aalen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Altenholz, , Germany

Site Status RECRUITING

Novartis Investigative Site

Aschaffenburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Augsburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Backnang, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bad Krozingen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bergneustadt, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bielefeld, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bochum, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bogen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bonn, , Germany

Site Status RECRUITING

Novartis Investigative Site

Chemnitz, , Germany

Site Status RECRUITING

Novartis Investigative Site

Coburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Dessau, , Germany

Site Status RECRUITING

Novartis Investigative Site

Dillingen Saar, , Germany

Site Status RECRUITING

Novartis Investigative Site

Dresden, , Germany

Site Status RECRUITING

Novartis Investigative Site

Duisburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Düsseldorf, , Germany

Site Status RECRUITING

Novartis Investigative Site

Düsseldorf, , Germany

Site Status RECRUITING

Novartis Investigative Site

Düsseldorf, , Germany

Site Status RECRUITING

Novartis Investigative Site

Eisleben Lutherstadt, , Germany

Site Status RECRUITING

Novartis Investigative Site

Eltville, , Germany

Site Status RECRUITING

Novartis Investigative Site

Erbach im Odenwald, , Germany

Site Status RECRUITING

Novartis Investigative Site

Erfurt, , Germany

Site Status RECRUITING

Novartis Investigative Site

Essen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Essen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Gelsenkirchen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Gelsenkirchen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Gera, , Germany

Site Status RECRUITING

Novartis Investigative Site

Göttingen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Hagen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Hamburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Hanover, , Germany

Site Status RECRUITING

Novartis Investigative Site

Heidenheim, , Germany

Site Status RECRUITING

Novartis Investigative Site

Herford, , Germany

Site Status RECRUITING

Novartis Investigative Site

Hoppegarten, , Germany

Site Status RECRUITING

Novartis Investigative Site

Höxter, , Germany

Site Status RECRUITING

Novartis Investigative Site

Itzehoe, , Germany

Site Status RECRUITING

Novartis Investigative Site

Karlsruhe, , Germany

Site Status RECRUITING

Novartis Investigative Site

Katzenelnbogen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Leipzig, , Germany

Site Status RECRUITING

Novartis Investigative Site

Lüneburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Magdeburg, , Germany

Site Status WITHDRAWN

Novartis Investigative Site

Magdeburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Merzig, , Germany

Site Status RECRUITING

Novartis Investigative Site

Minden, , Germany

Site Status RECRUITING

Novartis Investigative Site

München, , Germany

Site Status RECRUITING

Novartis Investigative Site

München, , Germany

Site Status RECRUITING

Novartis Investigative Site

Neuwied, , Germany

Site Status RECRUITING

Novartis Investigative Site

Osnabrück, , Germany

Site Status RECRUITING

Novartis Investigative Site

Pforzheim, , Germany

Site Status RECRUITING

Novartis Investigative Site

Quakenbrück, , Germany

Site Status RECRUITING

Novartis Investigative Site

Regensburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Remscheid, , Germany

Site Status RECRUITING

Novartis Investigative Site

Rülzheim, , Germany

Site Status RECRUITING

Novartis Investigative Site

Salzatal, , Germany

Site Status RECRUITING

Novartis Investigative Site

Schiltach, , Germany

Site Status WITHDRAWN

Novartis Investigative Site

Schwalmstadt-Treysa, , Germany

Site Status RECRUITING

Novartis Investigative Site

Schwäbisch Hall, , Germany

Site Status RECRUITING

Novartis Investigative Site

Siegen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Singen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Sinsheim, , Germany

Site Status RECRUITING

Novartis Investigative Site

Stadtroda, , Germany

Site Status RECRUITING

Novartis Investigative Site

Stuttgart, , Germany

Site Status RECRUITING

Novartis Investigative Site

Stuttgart, , Germany

Site Status RECRUITING

Novartis Investigative Site

Sundern Hachen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Tirschenreuth, , Germany

Site Status RECRUITING

Novartis Investigative Site

Ulm, , Germany

Site Status RECRUITING

Novartis Investigative Site

Unterhaching, , Germany

Site Status RECRUITING

Novartis Investigative Site

Velbert, , Germany

Site Status RECRUITING

Novartis Investigative Site

Weiden, , Germany

Site Status RECRUITING

Novartis Investigative Site

Weil der Stadt, , Germany

Site Status RECRUITING

Novartis Investigative Site

Witten, , Germany

Site Status RECRUITING

Novartis Investigative Site

Wolfenbüttel, , Germany

Site Status RECRUITING

Novartis Investigative Site

Wolfratshausen, , Germany

Site Status WITHDRAWN

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COMB157GDE04

Identifier Type: -

Identifier Source: org_study_id