RecruitingNCT05344469

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

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]

Sponsor

Novartis Pharmaceuticals

Enrollment

800 participants

Start Date

May 10, 2022

Study Type

OBSERVATIONAL

Conditions

Relapsing Multiple Sclerosis

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This observational study is monitoring patients with relapsing multiple sclerosis (MS) in real-world clinical practice to understand how different injectable and oral MS medications affect disease activity, disability, and quality of life over time. **You may be eligible if...** - You are 18 years or older with a diagnosis of multiple sclerosis - You have relapsing MS with active disease - You have had no more than 1 relapse in the past year (or 2 relapses in the past 2 years) - Your MS disability score (EDSS) is between 0 and 2.5 - You are starting or recently started an approved injectable or oral MS medication **You may NOT be eligible if...** - You have highly active or rapidly worsening MS requiring high-efficacy treatments immediately - You have been on the study medication for more than 14 days at enrollment (for Cohort 1) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERofatumumab

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

OTHERglatiramer acetate

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

OTHERinterferon β1

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

OTHERteriflunomide

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

OTHERdimethyl fumarate (DMF)

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

OTHERdiroximel fumarate (DRF)

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

Locations(127)

Novartis Investigative Site

Albstadt, Baden-Wurttemberg, Germany

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

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

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

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

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

Magdeburg, 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

Schneverdingen, 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

Tirschenreuth, Germany

Novartis Investigative Site

Trier, Germany

Novartis Investigative Site

Tübingen, Germany

Novartis Investigative Site

Velbert, Germany

Novartis Investigative Site

Weil der Stadt, Germany

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NCT05344469

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