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

NCT06551519 | Recruiting

• 1 other identifier: COMB157GDE04
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 109

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

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; MS; Ofatumumab; NIS; Germany

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with high serum neurofilament light (sNfL) levels

  Proportion of patients with high serum neurofilament light (sNfL) levels within 24 months of observation

  Up to 24 months

Secondary Outcomes (16)

• sNfL use as a biomarker for Multiple Sclerosis disease activity in clinical practice

  Up to 24 months

• Proportion of patients demonstrating radiological and / or clinical activity

  Up to 24 months

• Proportion of patients with no evidence of disease activity (NEDA)

  Baseline, month 12 and month 24

• Proportion of patients demonstrating NEDA 3 and its individual components at 24 months as compared to Baseline

  Baseline, 24 months

• Proportion of patients perceived as clinically stable depending on sNfL level

  Up to 24 months

Study Arms (2)

Ofatumumab

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

Other: ofatumumab

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.

Other: DMT category 1

Interventions

ofatumumab OTHER

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

Ofatumumab

DMT category 1 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.

Category 1 DMTs

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple sclerosis patients currently treated with a DMT category 1 prior to study start and receive sNfL measurements

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (109)

Novartis Investigative Site

Albstadt, Baden-Wurttemberg, 72458, Germany

RECRUITING

Novartis Investigative Site

Hettingen, Baden-Wurttemberg, 72513, Germany

RECRUITING

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68163, Germany

RECRUITING

Novartis Investigative Site

Schwetzingen, Baden-Wurttemberg, 68723, Germany

RECRUITING

Novartis Investigative Site

Bamberg, Bavaria, 96052, Germany

RECRUITING

Novartis Investigative Site

Neuburg A.d. Donau, Bavaria, 86633, Germany

RECRUITING

Novartis Investigative Site

Regensburg, Bavaria, 93059, Germany

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Novartis Investigative Site

Unterhaching, Bavaria, 82008, Germany

RECRUITING

Novartis Investigative Site

Untermeitingen, Bavaria, 86836, Germany

RECRUITING

Novartis Investigative Site

Weiden in Der Oberpfalz, Bavaria, 92637, Germany

RECRUITING

Novartis Investigative Site

Wolfratshausen, Bavaria, 82515, Germany

WITHDRAWN

Novartis Investigative Site

Hamburg, Hamburg, 22297, Germany

RECRUITING

Novartis Investigative Site

Bad Homburg, Hesse, 61348, Germany

RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, 60311, Germany

RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, 65929, Germany

RECRUITING

Novartis Investigative Site

Kassel, Hesse, 34121, Germany

RECRUITING

Novartis Investigative Site

Schwalmstadt, Hesse, 34613, Germany

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Novartis Investigative Site

Quakenbrück, Lower Saxony, 49610, Germany

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Novartis Investigative Site

Dortmund, North Rhine-Westphalia, 44135, Germany

RECRUITING

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, 44287, Germany

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Novartis Investigative Site

Gelsenkirchen, North Rhine-Westphalia, 45894, Germany

RECRUITING

Novartis Investigative Site

Meerbusch, North Rhine-Westphalia, 40667, Germany

RECRUITING

Novartis Investigative Site

Siegen, North Rhine-Westphalia, 57072, Germany

RECRUITING

Novartis Investigative Site

Sundern Sauerland, North Rhine-Westphalia, 59846, Germany

RECRUITING

Novartis Investigative Site

Chemnitz, Saxony, 09117, Germany

RECRUITING

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

RECRUITING

Novartis Investigative Site

Görlitz, Saxony, 02828, Germany

RECRUITING

Novartis Investigative Site

Leipzig, Saxony, 04299, Germany

RECRUITING

Novartis Investigative Site

Leipzig, Saxony, 04315, Germany

RECRUITING

Novartis Investigative Site

Altenburg, Thuringia, 04600, Germany

RECRUITING

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

RECRUITING

Novartis Investigative Site

Mühlhausen, Thuringia, 99974, Germany

RECRUITING

Novartis Investigative Site

Aalen, 73433, Germany

RECRUITING

Novartis Investigative Site

Altenholz, 24161, Germany

RECRUITING

Novartis Investigative Site

Alzey, 55232, Germany

WITHDRAWN

Novartis Investigative Site

Aschaffenburg, 63739, Germany

RECRUITING

Novartis Investigative Site

Augsburg, 86150, Germany

RECRUITING

Novartis Investigative Site

Backnang, 71522, Germany

RECRUITING

Novartis Investigative Site

Bad Krozingen, 79189, Germany

RECRUITING

Novartis Investigative Site

Bergneustadt, 51702, Germany

RECRUITING

Novartis Investigative Site

Berlin, 10437, Germany

RECRUITING

Novartis Investigative Site

Berlin, 12099, Germany

RECRUITING

Novartis Investigative Site

Berlin, 12163, Germany

RECRUITING

Novartis Investigative Site

Berlin, 12167, Germany

WITHDRAWN

Novartis Investigative Site

Berlin, 14057, Germany

RECRUITING

Novartis Investigative Site

Berlin, 14169, Germany

RECRUITING

Novartis Investigative Site

Bielefeld, 33647, Germany

COMPLETED

Novartis Investigative Site

Bochum, 44787, Germany

RECRUITING

Novartis Investigative Site

Bogen, 94327, Germany

RECRUITING

Novartis Investigative Site

Bonn, 53111, Germany

RECRUITING

Novartis Investigative Site

Chemnitz, 09117, Germany

RECRUITING

Novartis Investigative Site

Coburg, 96450, Germany

RECRUITING

Novartis Investigative Site

Crailsheim, 74564, Germany

RECRUITING

Novartis Investigative Site

Dessau, 06846, Germany

RECRUITING

Novartis Investigative Site

Dierdorf, 56269, Germany

RECRUITING

Novartis Investigative Site

Dillingen Saar, 66763, Germany

RECRUITING

Novartis Investigative Site

Dresden, 01067, Germany

RECRUITING

Novartis Investigative Site

Duisburg, 47138, Germany

RECRUITING

Novartis Investigative Site

Düsseldorf, 40211, Germany

RECRUITING

Novartis Investigative Site

Düsseldorf, 40237, Germany

RECRUITING

Novartis Investigative Site

Düsseldorf, 40625, Germany

RECRUITING

Novartis Investigative Site

Eisleben Lutherstadt, 06295, Germany

RECRUITING

Novartis Investigative Site

Eltville, 65343, Germany

WITHDRAWN

Novartis Investigative Site

Erbach im Odenwald, 64711, Germany

RECRUITING

Novartis Investigative Site

Erfurt, 99096, Germany

RECRUITING

Novartis Investigative Site

Essen, 45138, Germany

RECRUITING

Novartis Investigative Site

Essen, 45257, Germany

RECRUITING

Novartis Investigative Site

Gelsenkirchen, 45879, Germany

RECRUITING

Novartis Investigative Site

Gera, 07548, Germany

RECRUITING

Novartis Investigative Site

Göttingen, 37073, Germany

RECRUITING

Novartis Investigative Site

Hagen, 58099, Germany

RECRUITING

Novartis Investigative Site

Hamburg, 22179, Germany

RECRUITING

Novartis Investigative Site

Hanover, 30159, Germany

RECRUITING

Novartis Investigative Site

Heidenheim, 89518, Germany

RECRUITING

Novartis Investigative Site

Herford, 32049, Germany

RECRUITING

Novartis Investigative Site

Hoppegarten, 15366, Germany

RECRUITING

Novartis Investigative Site

Höxter, 37671, Germany

RECRUITING

Novartis Investigative Site

Itzehoe, 25524, Germany

RECRUITING

Novartis Investigative Site

Karlsruhe, 76133, Germany

RECRUITING

Novartis Investigative Site

Katzenelnbogen, 56368, Germany

RECRUITING

Novartis Investigative Site

Leipzig, 04109, Germany

RECRUITING

Novartis Investigative Site

Lüneburg, 21335, Germany

RECRUITING

Novartis Investigative Site

Magdeburg, 39104, Germany

WITHDRAWN

Novartis Investigative Site

Magdeburg, 39120, Germany

RECRUITING

Novartis Investigative Site

Merzig, 66663, Germany

RECRUITING

Novartis Investigative Site

Minden, 32423, Germany

RECRUITING

Novartis Investigative Site

München, 80939, Germany

RECRUITING

Novartis Investigative Site

München, 81675, Germany

RECRUITING

Novartis Investigative Site

Münster, 48149, Germany

RECRUITING

Novartis Investigative Site

Neuwied, 56564, Germany

RECRUITING

Novartis Investigative Site

Osnabrück, 49074, Germany

RECRUITING

Novartis Investigative Site

Pforzheim, 75172, Germany

RECRUITING

Novartis Investigative Site

Remscheid, 42853, Germany

RECRUITING

Novartis Investigative Site

Rülzheim, 76761, Germany

RECRUITING

Novartis Investigative Site

Salzatal, 06198, Germany

RECRUITING

Novartis Investigative Site

Schiltach, 77761, Germany

WITHDRAWN

Novartis Investigative Site

Schwäbisch Hall, 74523, Germany

RECRUITING

Novartis Investigative Site

Siegen, 57076, Germany

RECRUITING

Novartis Investigative Site

Singen, 78224, Germany

RECRUITING

Novartis Investigative Site

Sinsheim, 74889, Germany

RECRUITING

Novartis Investigative Site

Stadtroda, 07646, Germany

RECRUITING

Novartis Investigative Site

Stuttgart, 70174, Germany

RECRUITING

Novartis Investigative Site

Stuttgart, 70178, Germany

WITHDRAWN

Novartis Investigative Site

Tirschenreuth, 95643, Germany

RECRUITING

Novartis Investigative Site

Ulm, 89073, Germany

RECRUITING

Novartis Investigative Site

Velbert, 42551, Germany

RECRUITING

Novartis Investigative Site

Weil der Stadt, 71263, Germany

RECRUITING

Novartis Investigative Site

Witten, 58452, Germany

RECRUITING

Novartis Investigative Site

Wolfenbüttel, 38300, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): November 29, 2028
• Study Completion (Estimated): November 29, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (109)