A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis
NCT ID: NCT05344469
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
564 participants
OBSERVATIONAL
2022-05-10
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ofatumumab
Patients treated with ofatumumab
ofatumumab
There is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.
Standard of Care (SoC)
Patients treated with either interferon β1 (IFN-β1) or glatiramer acetate (GA)
glatiramer acetate
There is no treatment allocation. Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.
interferon β1
There is no treatment allocation. Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.
Interventions
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ofatumumab
There is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.
glatiramer acetate
There is no treatment allocation. Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.
interferon β1
There is no treatment allocation. Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.
Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
2. \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Hettingen, Baden-Wurttemberg, Germany
Novartis Investigative Site
Schwaebisch, Baden-Wurttemberg, Germany
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Schwetzingen, Baden-Wurttemberg, Germany
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Bamberg, Bavaria, Germany
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Untermeiting, Bavaria, Germany
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Bad Homburg, 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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Meerbusch, North Rhine-Westfalia, Germany
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Altenburg, , 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
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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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Bremen, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Dessau, , Germany
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Dillingen, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , 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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Frankfurt, , Germany
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Frankfurt, , Germany
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Fulda, , Germany
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Gelsenkirchen, , Germany
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Giessen, , Germany
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Gladenbach, , Germany
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Hagen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Jena, , Germany
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Kaiserslautern, , Germany
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Karlsruhe, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lünen, , Germany
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Mannheim, , Germany
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Marburg, , Germany
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Marburg, , Germany
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Mettmann, , Germany
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Minden, , Germany
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Montabaur, , Germany
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Mühlhausen, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Nagold, , Germany
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Neuburg an der Donau, , Germany
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Neuruppin, , Germany
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Osnabrück, , Germany
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Pforzheim, , Germany
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Potsdam, , Germany
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Regensburg, , 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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Saalouis, , 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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Unterhaching, , Germany
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Weil der Stadt, , Germany
Countries
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Other Identifiers
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COMB157GDE02
Identifier Type: -
Identifier Source: org_study_id
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