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Spanish study checks Real-World use of MS drug ofatumumab

NCT ID NCT06251986

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study in Spain looked at 310 people with relapsing multiple sclerosis who were taking ofatumumab (Kesimpta®). Researchers wanted to see how well the drug reduced relapses and how safe it was in everyday medical practice. The study collected information from medical records and patient visits to understand the drug's real-world effectiveness.

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 results are positive, this could confirm that ofatumumab is an effective and safe option for managing relapsing multiple sclerosis in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It also only looked at patients in Spain, 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

310 people

The number who actually took part.

Started

Feb 2024

Finished

Dec 2024

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 relapsing forms of multiple sclerosis (RMS) with active disease

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. Aged ≥ 18 years. 2. Written informed consent. 3. Diagnosis of RMS per McDonald Criteria (2017). 4. Ofatumumab treatment in line with the European Kesimpta® summary of product characteristics (SmPC; i.e. adult patients with RMS with active disease defined by clinical or imaging features) during at least 12 months and patients who discontinued ofatumumab after receiving at least one dose with a minimum monitoring of 12 months. Exclusion Criteria: 1. Currently participating in a clinical trial. 2. Not able/unlikely to complete with all study activities according to investigator's criteria. 3. Have a contraindication for ofatumumab use, according to the SmPC.

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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.

Relapsing forms of multiple sclerosis

Contacts and locations

Locations

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Palma, Balearic Islands, 07120, Spain

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Albacete, Castille-La Mancha, 02006, Spain

  • Novartis Investigative Site

    Salt, Girona, 17190, Spain

  • Novartis Investigative Site

    Logroño, La Rioja, 26006, Spain

  • Novartis Investigative Site

    Fuenlabrada, Madrid, 28942, Spain

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Vigo, Pontevedra, 36212, Spain

  • Novartis Investigative Site

    Santa Cruz, Santa Cruz de Tenerife, 38009, Spain

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903, Spain

  • Novartis Investigative Site

    Alicante, 03010, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Burgos, 09006, Spain

  • Novartis Investigative Site

    Cáceres, 10004, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Granada, 18016, Spain

  • Novartis Investigative Site

    León, 24080, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Seville, 41009, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Zaragoza, 50009, Spain

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