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Real-World study tracks why MS patients switch to kesimpta

NCT ID NCT05566756

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 307 people with relapsing multiple sclerosis in Germany who had recently switched to the drug Kesimpta (ofatumumab) from another treatment. Researchers collected information on why patients made the switch and how many doses they missed over one year. The goal was to understand real-world use of the medication, not to test if it works.

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

307 people

The number who actually took part.

Started

Oct 2022

Finished

May 2025

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 who previously received any approved DMT for RMS in Germany, and the decision to transition to ofatumumab therapy due to safety, tolerability, efficacy or other reasons was taken, will be eligible for enrollment

Ages

18 to 99 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.

Inclusion Criteria: 1. Written informed consent must be obtained before participating in the study 2. Diagnosis of RMS per McDonald Criteria (2017) (Thompson, Banwell et al. 2018) 3. Prior treatment with EU approved DMT for MS other than ofatumumab 4. Decision for treatment initiation of ofatumumab (Kesimpta®) prior to study participation and planned initiation of ofatumumab after respective wash-out period of prior DMT (if applicable) or performed initiation of ofatumumab within the last 14 days 5. Ofatumumab treatment in line with the German label Exclusion Criteria: 1. Use of investigational drugs during the study, OR within 3 months before ofatumumab initiation, OR within 5 half-lives of investigational drug before ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer 2. Subjects who are not able to provide consent due to incapable judgement 3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis

Contacts and locations

Locations

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 66163, Germany

  • Novartis Investigative Site

    Bamberg, Bavaria, 96052, Germany

  • Novartis Investigative Site

    Bad Homburg, Hesse, 61348, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60313, Germany

  • Novartis Investigative Site

    Marburg, Hesse, 35043, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50935, Germany

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45134, Germany

  • Novartis Investigative Site

    Altenburg, Thuringia, 04600, Germany

  • Novartis Investigative Site

    Alzey, 55232, Germany

  • Novartis Investigative Site

    Bayreuth, 95445, Germany

  • Novartis Investigative Site

    Berlin, 12099, Germany

  • Novartis Investigative Site

    Berlin, 13347, Germany

  • Novartis Investigative Site

    Berlin, 13357, Germany

  • Novartis Investigative Site

    Bochum, 44787, Germany

  • Novartis Investigative Site

    Bogen, 94327, Germany

  • Novartis Investigative Site

    Bonn, 53111, Germany

  • Novartis Investigative Site

    Böblingen, 71032, Germany

  • Novartis Investigative Site

    Chemnitz, 09117, Germany

  • Novartis Investigative Site

    Düsseldorf, 40211, Germany

  • Novartis Investigative Site

    Düsseldorf, 40625, Germany

  • Novartis Investigative Site

    Essen, 45257, Germany

  • Novartis Investigative Site

    Gelsenkirchen, 45894, Germany

  • Novartis Investigative Site

    Giessen, 35392, Germany

  • Novartis Investigative Site

    Gladenbach, 35075, Germany

  • Novartis Investigative Site

    Hagen, 58095, Germany

  • Novartis Investigative Site

    Hamburg, 20249, Germany

  • Novartis Investigative Site

    Hamburg, 22179, Germany

  • Novartis Investigative Site

    Hanover, 30625, Germany

  • Novartis Investigative Site

    Kaiserslautern, 67655, Germany

  • Novartis Investigative Site

    Minden, 32423, Germany

  • Novartis Investigative Site

    Osnabrück, 49074, Germany

  • Novartis Investigative Site

    Pforzheim, 75172, Germany

  • Novartis Investigative Site

    Quakenbrück, 49610, Germany

  • Novartis Investigative Site

    Remscheid, 42853, Germany

  • Novartis Investigative Site

    Rülzheim, 76761, Germany

  • Novartis Investigative Site

    Siegen, 57076, Germany

  • Novartis Investigative Site

    Sinsheim, 74889, Germany

  • Novartis Investigative Site

    Stuttgart, 70174, Germany

  • Novartis Investigative Site

    Stuttgart, 70182, Germany

  • Novartis Investigative Site

    Unterhaching, 82008, Germany

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