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800 MS patients to be tracked on common drugs – no new treatment tested

NCT ID NCT05344469

Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 5 times

Summary

This study is not testing a new drug. Instead, it will observe 800 people with relapsing multiple sclerosis in Germany who are already taking approved injectable or oral medications. Researchers will track how long patients stick with their prescribed treatment over up to four years, using questionnaires and medical records. The goal is to understand real-world treatment patterns, not to cure or control the disease directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    78 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Albstadt, Baden-Wurttemberg, 72458, Germany

  • Novartis Investigative Site

    COMPLETED

    Hettingen, Baden-Wurttemberg, 72513, Germany

  • Novartis Investigative Site

    RECRUITING

    Hettingen, Baden-Wurttemberg, 72513, Germany

  • Novartis Investigative Site

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68163, Germany

  • Novartis Investigative Site

    RECRUITING

    Nagold, Baden-Wurttemberg, 72202, Germany

  • Novartis Investigative Site

    RECRUITING

    Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

  • Novartis Investigative Site

    RECRUITING

    Schwetzingen, Baden-Wurttemberg, 68723, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bamberg, Bavaria, 96052, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Dillingen an der Donau, Bavaria, 89407, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Munich, Bavaria, 81241, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Munich, Bavaria, 81829, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

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

  • Novartis Investigative Site

    WITHDRAWN

    Regensburg, Bavaria, 93059, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Unterhaching, Bavaria, 82008, Germany

  • Novartis Investigative Site

    RECRUITING

    Untermeitingen, Bavaria, 86836, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Wolfratshausen, Bavaria, 82515, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Falkensee, Brandenburg, 14612, Germany

  • Novartis Investigative Site

    RECRUITING

    Bad Homburg, Hesse, 61348, Germany

  • Novartis Investigative Site

    COMPLETED

    Frankfurt am Main, Hesse, 60313, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Frankfurt am Main, Hesse, 65929, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Marburg, Hesse, 35043, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hanover, Lower Saxony, 30161, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hanover, Lower Saxony, 30449, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Wildeshausen, Lower Saxony, 27793, Germany

  • Novartis Investigative Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 50935, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Cologne, North Rhine-Westphalia, 51063, Germany

  • Novartis Investigative Site

    RECRUITING

    Dortmund, North Rhine-Westphalia, 44135, Germany

  • Novartis Investigative Site

    RECRUITING

    Dortmund, North Rhine-Westphalia, 44287, Germany

  • Novartis Investigative Site

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Essen, North Rhine-Westphalia, 45134, Germany

  • Novartis Investigative Site

    RECRUITING

    Gelsenkirchen, North Rhine-Westphalia, 45894, Germany

  • Novartis Investigative Site

    RECRUITING

    Meerbusch, North Rhine-Westphalia, 40667, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Münster, North Rhine-Westphalia, 48165, Germany

  • Novartis Investigative Site

    WITHDRAWN

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

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Siegen, North Rhine-Westphalia, 57072, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Ingelheim, Rhineland-Palatinate, 55218, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Saarlouis, Saarland, 66740, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Chemnitz, Saxony, 09117, Germany

  • Novartis Investigative Site

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    RECRUITING

    Görlitz, Saxony, 02828, Germany

  • Novartis Investigative Site

    COMPLETED

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Leipzig, Saxony, 04315, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Altmark, Saxony-Anhalt, 39629, Germany

  • Novartis Investigative Site

    RECRUITING

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    COMPLETED

    Altenburg, Thuringia, 04600, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Altenburg, Thuringia, 04600, Germany

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Mühlhausen, Thuringia, 99974, Germany

  • Novartis Investigative Site

    RECRUITING

    Aalen, 73433, Germany

  • Novartis Investigative Site

    RECRUITING

    Altenholz, 24161, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Alzey, 55232, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bamberg, 96047, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bayreuth, 95445, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Bergneustadt, 51702, Germany

  • Novartis Investigative Site

    RECRUITING

    Bergneustadt, 51702, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Berlin, 10437, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Berlin, 10713, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 12099, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Berlin, 12099, Germany

  • Novartis Investigative Site

    COMPLETED

    Berlin, 12099, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 12163, Germany

  • Novartis Investigative Site

    COMPLETED

    Berlin, 12351, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Berlin, 13357, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 14057, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Berlin, 14169, Germany

  • Novartis Investigative Site

    RECRUITING

    Bochum, 44787, Germany

  • Novartis Investigative Site

    RECRUITING

    Bochum, 44791, Germany

  • Novartis Investigative Site

    RECRUITING

    Bogen, 94327, Germany

  • Novartis Investigative Site

    RECRUITING

    Bonn, 53111, Germany

  • Novartis Investigative Site

    RECRUITING

    Böblingen, 71032, Germany

  • Novartis Investigative Site

    RECRUITING

    Braunschweig, 38100, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bremen, 28195, Germany

  • Novartis Investigative Site

    RECRUITING

    Chemnitz, 09117, Germany

  • Novartis Investigative Site

    RECRUITING

    Coburg, 96450, Germany

  • Novartis Investigative Site

    RECRUITING

    Crailsheim, 74564, Germany

  • Novartis Investigative Site

    RECRUITING

    Dessau, 06846, Germany

  • Novartis Investigative Site

    RECRUITING

    Dillingen Saar, 66763, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Dresden, 01067, Germany

  • Novartis Investigative Site

    RECRUITING

    Dresden, 01097, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Duisburg, 47138, Germany

  • Novartis Investigative Site

    RECRUITING

    Duisburg, 47138, Germany

  • Novartis Investigative Site

    COMPLETED

    Düsseldorf, 40211, Germany

  • Novartis Investigative Site

    RECRUITING

    Düsseldorf, 40211, Germany

  • Novartis Investigative Site

    RECRUITING

    Düsseldorf, 40625, Germany

  • Novartis Investigative Site

    RECRUITING

    Eisleben Lutherstadt, 06295, Germany

  • Novartis Investigative Site

    RECRUITING

    Eltville, 65343, Germany

  • Novartis Investigative Site

    RECRUITING

    Erbach im Odenwald, 64711, Germany

  • Novartis Investigative Site

    RECRUITING

    Erfurt, 99096, Germany

  • Novartis Investigative Site

    RECRUITING

    Erfurt, 99099, Germany

  • Novartis Investigative Site

    RECRUITING

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45138, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45257, Germany

  • Novartis Investigative Site

    COMPLETED

    Fulda, 36037, Germany

  • Novartis Investigative Site

    RECRUITING

    Fulda, 36037, Germany

  • Novartis Investigative Site

    RECRUITING

    Giessen, 35392, Germany

  • Novartis Investigative Site

    RECRUITING

    Gladenbach, 35075, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hagen, 58095, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 20249, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 22179, Germany

  • Novartis Investigative Site

    RECRUITING

    Hanover, 30625, Germany

  • Novartis Investigative Site

    RECRUITING

    Höxter, 37671, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Itzehoe, 25524, Germany

  • Novartis Investigative Site

    RECRUITING

    Kaiserslautern, 67655, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Karlsruhe, 76133, Germany

  • Novartis Investigative Site

    RECRUITING

    Karlsruhe, 76133, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Lünen, 44534, Germany

  • Novartis Investigative Site

    RECRUITING

    Magdeburg, 39104, Germany

  • Novartis Investigative Site

    COMPLETED

    Marburg, 35037, Germany

  • Novartis Investigative Site

    RECRUITING

    Merzig, 66663, Germany

  • Novartis Investigative Site

    COMPLETED

    Mettmann, 40822, Germany

  • Novartis Investigative Site

    COMPLETED

    Minden, 32429, Germany

  • Novartis Investigative Site

    COMPLETED

    Montabaur, 56410, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Mülheim, 45468, Germany

  • Novartis Investigative Site

    RECRUITING

    München, 80939, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    München, 81675, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48149, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Neuruppin, 16816, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Nuremberg, 90491, Germany

  • Novartis Investigative Site

    RECRUITING

    Oldenburg, 26121, Germany

  • Novartis Investigative Site

    RECRUITING

    Osnabrück, 49074, Germany

  • Novartis Investigative Site

    RECRUITING

    Pforzheim, 75172, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Potsdam, 14471, Germany

  • Novartis Investigative Site

    RECRUITING

    Remscheid, 42853, Germany

  • Novartis Investigative Site

    COMPLETED

    Rostock, 18057, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Rüdersdorf, 15562, Germany

  • Novartis Investigative Site

    RECRUITING

    Rülzheim, 76761, Germany

  • Novartis Investigative Site

    RECRUITING

    Salzatal, 06198, Germany

  • Novartis Investigative Site

    RECRUITING

    Schiltach, 77761, Germany

  • Novartis Investigative Site

    RECRUITING

    Schneverdingen, 29640, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Siegen, 57076, Germany

  • Novartis Investigative Site

    RECRUITING

    Siegen, 57076, Germany

  • Novartis Investigative Site

    RECRUITING

    Sinsheim, 74889, Germany

  • Novartis Investigative Site

    RECRUITING

    Stadtroda, 07646, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Stuttgart, 70174, Germany

  • Novartis Investigative Site

    RECRUITING

    Stuttgart, 70176, Germany

  • Novartis Investigative Site

    COMPLETED

    Stuttgart, 70182, Germany

  • Novartis Investigative Site

    RECRUITING

    Tirschenreuth, 95643, Germany

  • Novartis Investigative Site

    RECRUITING

    Trier, 54292, Germany

  • Novartis Investigative Site

    RECRUITING

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    RECRUITING

    Velbert, 42551, Germany

  • Novartis Investigative Site

    RECRUITING

    Weil der Stadt, 71263, Germany

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