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RECRUITING

NCT05344469

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2022-05-10

Completion Date

2029-05-30

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Relapsing Multiple Sclerosis

Interventions

OTHER

ofatumumab

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

OTHER

glatiramer acetate

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

OTHER

interferon β1

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

OTHER

teriflunomide

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

OTHER

dimethyl fumarate (DMF)

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

OTHER

diroximel fumarate (DRF)

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

Cohort 1 Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Male or female patients aged ≥18 years at enrollment 3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b) 4. RMS with active disease as defined by Lublin et al. (2014) 5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment 6. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive) 7. Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment Cohort 2 Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation, 2. Male or female patients aged ≥18 years at enrollment, 3. Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025), 4. RMS with active disease as defined by Lublin et al. (2014) , 5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment, 6. Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive), 7. 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 * IFN-β1, GA, teriflunomide, DMF or DRF: only naïve patients Cohort 1 Exclusion Criteria: 1. Patients being treated outside of the approved label 2. \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment 3. Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7) 4. 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 5. Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator 6. EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment 7. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab Cohort 2 Exclusion Criteria: 1. Patients being treated outside of the approved label, 2. \>5 years since first symptom(s) (leading to MS diagnosis) at enrollment, 3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab, 4. Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2

Locations (119)

Novartis Investigative Site

Hettingen, Baden-Wurttemberg, Germany

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Nagold, Baden-Wurttemberg, Germany

Novartis Investigative Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

Novartis Investigative Site

Schwetzingen, Baden-Wurttemberg, Germany

Novartis Investigative Site

Bamberg, Bavaria, Germany

Novartis Investigative Site

Dillingen an der Donau, Bavaria, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Neuburg A.d. Donau, Bavaria, Germany

Novartis Investigative Site

Regensburg, Bavaria, Germany

Novartis Investigative Site

Unterhaching, Bavaria, Germany

Novartis Investigative Site

Untermeitingen, Bavaria, Germany

Novartis Investigative Site

Wolfratshausen, Bavaria, Germany

Novartis Investigative Site

Falkensee, Brandenburg, Germany

Novartis Investigative Site

Bad Homburg, Hesse, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Marburg, Hesse, Germany

Novartis Investigative Site

Hanover, Lower Saxony, Germany

Novartis Investigative Site

Hanover, Lower Saxony, Germany

Novartis Investigative Site

Wildeshausen, Lower Saxony, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, Germany

Novartis Investigative Site

Dortmund, North Rhine-Westphalia, Germany

Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, Germany

Novartis Investigative Site

Essen, North Rhine-Westphalia, Germany

Novartis Investigative Site

Gelsenkirchen, North Rhine-Westphalia, Germany

Novartis Investigative Site

Meerbusch, North Rhine-Westphalia, Germany

Novartis Investigative Site

Münster, North Rhine-Westphalia, Germany

Novartis Investigative Site

Oer-Erkenschwick, North Rhine-Westphalia, Germany

Novartis Investigative Site

Ingelheim, Rhineland-Palatinate, Germany

Novartis Investigative Site

Saarlouis, Saarland, Germany

Novartis Investigative Site

Chemnitz, Saxony, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Altmark, Saxony-Anhalt, Germany

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Novartis Investigative Site

Altenburg, Thuringia, Germany

Novartis Investigative Site

Altenburg, Thuringia, Germany

Novartis Investigative Site

Jena, Thuringia, Germany

Novartis Investigative Site

Mühlhausen, Thuringia, Germany

Novartis Investigative Site

Altenholz, Germany

Novartis Investigative Site

Alzey, Germany

Novartis Investigative Site

Bamberg, Germany

Novartis Investigative Site

Bayreuth, Germany

Novartis Investigative Site

Bergneustadt, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bochum, Germany

Novartis Investigative Site

Bochum, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Böblingen, Germany

Novartis Investigative Site

Braunschweig, Germany

Novartis Investigative Site

Bremen, Germany

Novartis Investigative Site

Chemnitz, Germany

Novartis Investigative Site

Coburg, Germany

Novartis Investigative Site

Crailsheim, Germany

Novartis Investigative Site

Dessau, Germany

Novartis Investigative Site

Dresden, Germany

Novartis Investigative Site

Dresden, Germany

Novartis Investigative Site

Duisburg, Germany

Novartis Investigative Site

Düsseldorf, Germany

Novartis Investigative Site

Düsseldorf, Germany

Novartis Investigative Site

Eisleben Lutherstadt, Germany

Novartis Investigative Site

Eltville, Germany

Novartis Investigative Site

Erbach im Odenwald, Germany

Novartis Investigative Site

Erfurt, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Fulda, Germany

Novartis Investigative Site

Giessen, Germany

Novartis Investigative Site

Gladenbach, Germany

Novartis Investigative Site

Hagen, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Hanover, Germany

Novartis Investigative Site

Höxter, Germany

Novartis Investigative Site

Itzehoe, Germany

Novartis Investigative Site

Kaiserslautern, Germany

Novartis Investigative Site

Karlsruhe, Germany

Novartis Investigative Site

Lünen, Germany

Novartis Investigative Site

Marburg, Germany

Novartis Investigative Site

Mettmann, Germany

Novartis Investigative Site

Minden, Germany

Novartis Investigative Site

Montabaur, Germany

Novartis Investigative Site

Mülheim, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Münster, Germany

Novartis Investigative Site

Neuruppin, Germany

Novartis Investigative Site

Nuremberg, Germany

Novartis Investigative Site

Osnabrück, Germany

Novartis Investigative Site

Pforzheim, Germany

Novartis Investigative Site

Potsdam, Germany

Novartis Investigative Site

Remscheid, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Rüdersdorf, Germany

Novartis Investigative Site

Rülzheim, Germany

Novartis Investigative Site

Salzatal, Germany

Novartis Investigative Site

Siegen, Germany

Novartis Investigative Site

Stadtroda, Germany

Novartis Investigative Site

Stuttgart, Germany

Novartis Investigative Site

Stuttgart, Germany

Novartis Investigative Site

Stuttgart, Germany

Novartis Investigative Site

Trier, Germany

Novartis Investigative Site

Tübingen, Germany

Novartis Investigative Site

Velbert, Germany

Novartis Investigative Site

Weil der Stadt, Germany

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (119)