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Real-World study tests MS drug ofatumumab in greek clinics

NCT ID NCT06486779

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study follows 160 people with relapsing multiple sclerosis in Greece who are already taking ofatumumab (Kesimpta®) as part of their routine care. Researchers will track how many patients have no signs of disease activity—like relapses, new brain lesions, or worsening disability—over time. The goal is to see if the drug works as well in real-world settings as it did in earlier clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ofatumumab (Kesimpta®)
What this could lead to
If successful, this study could confirm that ofatumumab works as well in everyday clinics as it does in controlled trials, supporting its use for relapsing MS.
What could go wrong
This is an observational study, not a controlled experiment, so results may be influenced by patient selection or other factors. It is also limited to Greece, so findings may not apply everywhere.

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 160 people

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

Started

Dec 2024

Expected to finish

Dec 2028

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

Adult patients with RMS who have initiated treatment with ofatumumab early in their disease course. Patients will have been administered ofatumumab (Kesimpta®) three to six months prior to informed consent (IC) and will continue to be treated according to the local product's prescribing information and routine medical practice in terms of visit frequency and type of assessments performed, after enrolment.

Ages

18 to 55 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 IC must be obtained before participating in the study. 2. Patients with diagnosis of RMS per McDonald Criteria (2017) and \<5 years since first MS symptom prior to initiation of ofatumumab. 3. Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study. 4. Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features). 5. Patients with at least one available brain MRI scan performed at least 3 months after ofatumumab initiation OR for whom the physician (as per her/his routine practice and independently of his/her decision to include the patient in the current study) plans to perform such scanning within 31 days after patient's inclusion in the study. Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In case it is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatment should be brain gadolinium enhanced, for relevant comparison and identification of new lesions. This MRI scan will serve as the index reference assessment for the evaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy. 6. Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study. Exclusion Criteria: 1. Use of investigational drugs during the study, OR between ofatumumab initiation and inclusion into 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. Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.

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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 (RMS)

How to take part

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

  1. The places running it

    14 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

    Athens, Attica, 15562, Greece

  • Novartis Investigative Site

    RECRUITING

    Athens, GR, 115 26, Greece

  • Novartis Investigative Site

    RECRUITING

    Alexandroupoli, 681 00, Greece

  • Novartis Investigative Site

    RECRUITING

    Athens, 115 21, Greece

  • Novartis Investigative Site

    RECRUITING

    Athens, 115 25, Greece

  • Novartis Investigative Site

    RECRUITING

    Athens, 115 27, Greece

  • Novartis Investigative Site

    WITHDRAWN

    Athens, 115 28, Greece

  • Novartis Investigative Site

    RECRUITING

    Athens, 145 61, Greece

  • Novartis Investigative Site

    RECRUITING

    Chaïdári, 124 62, Greece

  • Novartis Investigative Site

    RECRUITING

    Crete Heraklion, 714 09, Greece

  • Novartis Investigative Site

    RECRUITING

    Ioannina, 455 00, Greece

  • Novartis Investigative Site

    RECRUITING

    Larissa, 411 10, Greece

  • Novartis Investigative Site

    RECRUITING

    Pátrai, 265 04, Greece

  • Novartis Investigative Site

    RECRUITING

    Thessaloniki, 53246, Greece

  • Novartis Investigative Site

    RECRUITING

    Thessaloniki, 54636, Greece

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