A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis

NCT05344469 | Recruiting

• 1 other identifier: COMB157GDE02
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 127

Brief Summary

This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.

Conditions

Relapsing Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis; RMS; NIS; ofatumumab

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who continue to receive their baseline treatment

  Proportion of patients who continue to receive their baseline treatment \[ofatumumab or other approved disease modifying therapies (IFN-β1, GA, teriflunomide, DMF or DRF)\]

  Month 24

Secondary Outcomes (49)

• Proportion of patients who continue to receive their baseline treatment

  Month 12

• Time to event analysis for retention time on baseline treatment

  From Baseline to event, up to 24 months

• Impact of first-line treatment on health economy

  Baseline, month 6, month 12, month 18 and month 24

• Fatigue Symptoms and Impact Questionnaire-RMS

  Baseline, month 3, month 6, month 12, month 18, month 24

• Patient Health Questionnaire 8 [PHQ-8]

  Baseline, month 3, month 6, month 12, month 18, month 24

Study Arms (2)

Ofatumumab

Patients treated with ofatumumab

Other: ofatumumab

Standard of Care (SoC)

Patients treated with either interferon β1 (IFN-β1), glatiramer acetate (GA), teriflunomide, dimethyl fumarate (DMF) or diroximel fumarate (DRF)

Other: glatiramer acetate; Other: interferon β1; Other: teriflunomide; Other: dimethyl fumarate (DMF); Other: diroximel fumarate (DRF)

Interventions

interferon β1 OTHER

There is no treatment allocation. Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.

Standard of Care (SoC)

teriflunomide OTHER

There is no treatment allocation. Patients administered teriflunomide by prescription that have started as routine medical treatment will be enrolled.

Standard of Care (SoC)

dimethyl fumarate (DMF) OTHER

There is no treatment allocation. Patients administered dimethyl fumarate (DMF) by prescription that have started as routine medical treatment will be enrolled.

Standard of Care (SoC)

ofatumumab OTHER

There is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.

Ofatumumab

glatiramer acetate OTHER

There is no treatment allocation. Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.

Standard of Care (SoC)

diroximel fumarate (DRF) OTHER

There is no treatment allocation. Patients administered diroximel fumarate (DRF) by prescription that have started as routine medical treatment will be enrolled.

Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study
• Male or female patients aged ≥18 years at enrollment
• Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
• RMS with active disease as defined by Lublin et al. (2014)
• Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
• Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
• Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment
• Signed informed consent must be obtained prior to participation,
• Male or female patients aged ≥18 years at enrollment,
• Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),
• RMS with active disease as defined by Lublin et al. (2014) ,
• Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment,
• Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive),
• Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment:
• Ofatumumab: only naïve patients or patients previously treated with max. one DMT other than ofatumumab

You may not qualify if:

• Patients being treated outside of the approved label
• \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
• Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
• Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
• EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
• Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab
• Patients being treated outside of the approved label,
• \>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,
• Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,
• Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (127)

Novartis Investigative Site

Albstadt, Baden-Wurttemberg, 72458, Germany

RECRUITING

Novartis Investigative Site

Hettingen, Baden-Wurttemberg, 72513, Germany

COMPLETED

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68163, Germany

RECRUITING

Novartis Investigative Site

Nagold, Baden-Wurttemberg, 72202, Germany

RECRUITING

Novartis Investigative Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

RECRUITING

Novartis Investigative Site

Schwetzingen, Baden-Wurttemberg, 68723, Germany

RECRUITING

Novartis Investigative Site

Bamberg, Bavaria, 96052, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Dillingen an der Donau, Bavaria, 89407, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Munich, Bavaria, 81241, Germany

WITHDRAWN

Novartis Investigative Site

Munich, Bavaria, 81829, Germany

WITHDRAWN

Novartis Investigative Site

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

ACTIVE NOT RECRUITING

Novartis Investigative Site

Regensburg, Bavaria, 93059, Germany

WITHDRAWN

Novartis Investigative Site

Unterhaching, Bavaria, 82008, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Untermeitingen, Bavaria, 86836, Germany

RECRUITING

Novartis Investigative Site

Wolfratshausen, Bavaria, 82515, Germany

WITHDRAWN

Novartis Investigative Site

Falkensee, Brandenburg, 14612, Germany

WITHDRAWN

Novartis Investigative Site

Bad Homburg, Hesse, 61348, Germany

RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, 60313, Germany

COMPLETED

Novartis Investigative Site

Frankfurt am Main, Hesse, 65929, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Marburg, Hesse, 35043, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Hanover, Lower Saxony, 30161, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Hanover, Lower Saxony, 30449, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Wildeshausen, Lower Saxony, 27793, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50935, Germany

RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 51063, Germany

WITHDRAWN

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, 44135, Germany

RECRUITING

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, 44287, Germany

RECRUITING

Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Novartis Investigative Site

Essen, North Rhine-Westphalia, 45134, Germany

WITHDRAWN

Novartis Investigative Site

Gelsenkirchen, North Rhine-Westphalia, 45894, Germany

RECRUITING

Novartis Investigative Site

Meerbusch, North Rhine-Westphalia, 40667, Germany

RECRUITING

Novartis Investigative Site

Münster, North Rhine-Westphalia, 48165, Germany

WITHDRAWN

Novartis Investigative Site

Oer-Erkenschwick, North Rhine-Westphalia, 45739, Germany

WITHDRAWN

Novartis Investigative Site

Ingelheim, Rhineland-Palatinate, 55218, Germany

WITHDRAWN

Novartis Investigative Site

Saarlouis, Saarland, 66740, Germany

WITHDRAWN

Novartis Investigative Site

Chemnitz, Saxony, 09117, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

RECRUITING

Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

COMPLETED

Novartis Investigative Site

Leipzig, Saxony, 04315, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Altmark, Saxony-Anhalt, 39629, Germany

WITHDRAWN

Novartis Investigative Site

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Novartis Investigative Site

Altenburg, Thuringia, 04600, Germany

COMPLETED

Novartis Investigative Site

Altenburg, Thuringia, 04600, Germany

WITHDRAWN

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

RECRUITING

Novartis Investigative Site

Mühlhausen, Thuringia, 99974, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Altenholz, 24161, Germany

RECRUITING

Novartis Investigative Site

Alzey, 55232, Germany

WITHDRAWN

Novartis Investigative Site

Bamberg, 96047, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Bayreuth, 95445, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Bergneustadt, 51702, Germany

WITHDRAWN

Novartis Investigative Site

Bergneustadt, 51702, Germany

RECRUITING

Novartis Investigative Site

Berlin, 10437, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Berlin, 10713, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Berlin, 12099, Germany

RECRUITING

Novartis Investigative Site

Berlin, 12099, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Berlin, 12099, Germany

COMPLETED

Novartis Investigative Site

Berlin, 12163, Germany

RECRUITING

Novartis Investigative Site

Berlin, 12351, Germany

COMPLETED

Novartis Investigative Site

Berlin, 13357, Germany

WITHDRAWN

Novartis Investigative Site

Berlin, 14169, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Bochum, 44787, Germany

RECRUITING

Novartis Investigative Site

Bochum, 44791, Germany

RECRUITING

Novartis Investigative Site

Bonn, 53111, Germany

RECRUITING

Novartis Investigative Site

Böblingen, 71032, Germany

RECRUITING

Novartis Investigative Site

Braunschweig, 38100, Germany

RECRUITING

Novartis Investigative Site

Bremen, 28195, Germany

ACTIVE NOT 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

Dresden, 01067, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Dresden, 01097, Germany

RECRUITING

Novartis Investigative Site

Duisburg, 47138, Germany

WITHDRAWN

Novartis Investigative Site

Düsseldorf, 40211, Germany

COMPLETED

Novartis Investigative Site

Düsseldorf, 40211, Germany

RECRUITING

Novartis Investigative Site

Düsseldorf, 40625, Germany

RECRUITING

Novartis Investigative Site

Eisleben Lutherstadt, 06295, Germany

RECRUITING

Novartis Investigative Site

Eltville, 65343, Germany

RECRUITING

Novartis Investigative Site

Erbach im Odenwald, 64711, Germany

RECRUITING

Novartis Investigative Site

Erfurt, 99096, Germany

RECRUITING

Novartis Investigative Site

Erfurt, 99099, Germany

RECRUITING

Novartis Investigative Site

Erlangen, 91054, Germany

RECRUITING

Novartis Investigative Site

Essen, 45138, Germany

RECRUITING

Novartis Investigative Site

Essen, 45257, Germany

RECRUITING

Novartis Investigative Site

Fulda, 36037, Germany

COMPLETED

Novartis Investigative Site

Fulda, 36037, Germany

RECRUITING

Novartis Investigative Site

Giessen, 35392, Germany

RECRUITING

Novartis Investigative Site

Gladenbach, 35075, Germany

RECRUITING

Novartis Investigative Site

Hagen, 58095, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Hamburg, 20249, Germany

RECRUITING

Novartis Investigative Site

Hamburg, 22179, Germany

RECRUITING

Novartis Investigative Site

Hanover, 30625, Germany

RECRUITING

Novartis Investigative Site

Höxter, 37671, Germany

RECRUITING

Novartis Investigative Site

Itzehoe, 25524, Germany

WITHDRAWN

Novartis Investigative Site

Kaiserslautern, 67655, Germany

RECRUITING

Novartis Investigative Site

Karlsruhe, 76133, Germany

WITHDRAWN

Novartis Investigative Site

Lünen, 44534, Germany

WITHDRAWN

Novartis Investigative Site

Magdeburg, 39104, Germany

RECRUITING

Novartis Investigative Site

Marburg, 35037, Germany

COMPLETED

Novartis Investigative Site

Mettmann, 40822, Germany

COMPLETED

Novartis Investigative Site

Minden, 32429, Germany

COMPLETED

Novartis Investigative Site

Montabaur, 56410, Germany

COMPLETED

Novartis Investigative Site

Mülheim, 45468, Germany

WITHDRAWN

Novartis Investigative Site

München, 80939, Germany

RECRUITING

Novartis Investigative Site

München, 81675, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Münster, 48149, Germany

RECRUITING

Novartis Investigative Site

Neuruppin, 16816, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Nuremberg, 90491, Germany

WITHDRAWN

Novartis Investigative Site

Osnabrück, 49074, Germany

RECRUITING

Novartis Investigative Site

Pforzheim, 75172, Germany

RECRUITING

Novartis Investigative Site

Potsdam, 14471, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Remscheid, 42853, Germany

RECRUITING

Novartis Investigative Site

Rostock, 18057, Germany

COMPLETED

Novartis Investigative Site

Rüdersdorf, 15562, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Rülzheim, 76761, Germany

RECRUITING

Novartis Investigative Site

Salzatal, 06198, Germany

RECRUITING

Novartis Investigative Site

Schneverdingen, 29640, Germany

RECRUITING

Novartis Investigative Site

Siegen, 57076, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Stadtroda, 07646, Germany

RECRUITING

Novartis Investigative Site

Stuttgart, 70174, Germany

ACTIVE NOT RECRUITING

Novartis Investigative Site

Stuttgart, 70176, Germany

RECRUITING

Novartis Investigative Site

Stuttgart, 70182, Germany

COMPLETED

Novartis Investigative Site

Tirschenreuth, 95643, Germany

RECRUITING

Novartis Investigative Site

Trier, 54292, Germany

RECRUITING

Novartis Investigative Site

Tübingen, 72076, Germany

RECRUITING

Novartis Investigative Site

Velbert, 42551, Germany

RECRUITING

Novartis Investigative Site

Weil der Stadt, 71263, Germany

RECRUITING

MeSH Terms

Interventions

ofatumumab; Glatiramer Acetate; teriflunomide; Dimethyl Fumarate; diroximel fumarate

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: May 10, 2022
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (127)