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A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
NCT05344469 · Novartis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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]
About this study
The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable or oral DMT for RMS as routine medical treatment. This decision must have been made prior to enrollment in this study.
Cohort 1: The prospective observational period per patient in the core part will be up to approx. two years from the time of consent (2 years +2 months visit window). If a patient re-consents to the extension part, then the prospective extension observational period will be additional approx. two years, resulting in a total observational period (prospectively for the core and extension part \& retrospectively for the potential gap between core and extension part) of approx. 4 years (+ 2 month visit window).
Cohort 2: The prospective observational period per patient will be up to approx. two years from the time of consent (2 years + 2 months visit window).
The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.
Eligibility criteria
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
Study design
Enrollment target: 800 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-05-10
Estimated completion: 2029-05-30
Last updated: 2026-04-01
Interventions
Other: ofatumumabOther: glatiramer acetateOther: interferon β1Other: teriflunomideOther: dimethyl fumarate (DMF)Other: diroximel fumarate (DRF)
Primary outcomes
- • Proportion of patients who continue to receive their baseline treatment (Month 24)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
ContactNovartis Pharmaceuticals · contact
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (119)
Novartis Investigative SiteCompleted
Hettingen, Baden-Wurttemberg, Germany
Novartis Investigative SiteRecruiting
Mannheim, Baden-Wurttemberg, Germany
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Nagold, Baden-Wurttemberg, Germany
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Schwäbisch Hall, Baden-Wurttemberg, Germany
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Schwetzingen, Baden-Wurttemberg, Germany
Novartis Investigative SiteActive Not Recruiting
Bamberg, Bavaria, Germany
Novartis Investigative SiteActive Not Recruiting
Dillingen an der Donau, Bavaria, Germany
Novartis Investigative SiteWithdrawn
Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Neuburg A.d. Donau, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Unterhaching, Bavaria, Germany
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Untermeitingen, Bavaria, Germany
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Wolfratshausen, Bavaria, Germany
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Falkensee, Brandenburg, Germany
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Bad Homburg, Hesse, Germany
Novartis Investigative SiteCompleted
Frankfurt am Main, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Marburg, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Wildeshausen, Lower Saxony, Germany
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Cologne, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Gelsenkirchen, North Rhine-Westphalia, Germany
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Meerbusch, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Oer-Erkenschwick, North Rhine-Westphalia, Germany
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Ingelheim, Rhineland-Palatinate, Germany
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Saarlouis, Saarland, Germany
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Chemnitz, Saxony, Germany
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Dresden, Saxony, Germany
Novartis Investigative SiteCompleted
Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Altmark, Saxony-Anhalt, Germany
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Halle, Saxony-Anhalt, Germany
Novartis Investigative SiteCompleted
Altenburg, Thuringia, Germany
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Altenburg, Thuringia, Germany
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Jena, Thuringia, Germany
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Mühlhausen, Thuringia, Germany
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Altenholz, Germany
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Alzey, Germany
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Bamberg, Germany
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Bayreuth, Germany
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Bergneustadt, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
Novartis Investigative SiteCompleted
Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Bochum, Germany
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Bochum, Germany
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Bonn, Germany
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Böblingen, Germany
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Braunschweig, Germany
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Bremen, Germany
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Chemnitz, Germany
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Coburg, Germany
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Crailsheim, Germany
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Dessau, Germany
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Dresden, Germany
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Dresden, Germany
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Duisburg, Germany
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Düsseldorf, Germany
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Düsseldorf, Germany
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Eisleben Lutherstadt, Germany
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Eltville, Germany
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Erbach im Odenwald, Germany
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Erfurt, Germany
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Erlangen, Germany
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Essen, Germany
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Essen, Germany
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Fulda, Germany
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Giessen, Germany
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Gladenbach, Germany
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Hagen, Germany
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Hamburg, Germany
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Hamburg, Germany
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Hanover, Germany
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Höxter, Germany
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Itzehoe, Germany
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Kaiserslautern, Germany
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Karlsruhe, Germany
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Lünen, Germany
Novartis Investigative SiteCompleted
Marburg, Germany
Novartis Investigative SiteCompleted
Mettmann, Germany
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Minden, Germany
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Montabaur, Germany
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Mülheim, Germany
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München, Germany
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München, Germany
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Münster, Germany
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Neuruppin, Germany
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Nuremberg, Germany
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Osnabrück, Germany
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Pforzheim, Germany
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Potsdam, Germany
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Remscheid, Germany
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Rostock, Germany
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Rüdersdorf, Germany
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Rülzheim, Germany
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Salzatal, Germany
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Siegen, Germany
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Stadtroda, Germany
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Stuttgart, Germany
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Stuttgart, Germany
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Stuttgart, Germany
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Trier, Germany
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Tübingen, Germany
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Velbert, Germany
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Weil der Stadt, Germany