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Timing of MS drug may change disease course

NCT ID NCT05809986

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study looks at Portuguese adults with relapsing multiple sclerosis who are taking ofatumumab (Kesimpta). It compares those who started the drug within three years of diagnosis to those who started later. The goal is to see if earlier treatment leads to less disease activity, such as fewer relapses or brain lesions.

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 early treatment proves more effective, it may support starting ofatumumab soon after diagnosis to better control multiple sclerosis.
What could go wrong
This is an observational study, not a controlled trial, so results may show correlation, not causation. Individual responses vary, and long-term risks remain unknown.

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 174 people

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

Started

Nov 2023

Expected to finish

Dec 2026

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

The study population will include male and female patients (aged ≥ 18 years) with a documented diagnosis of RMS and with Ofatumumab treatment in line with the Portuguese label i.e., adult patients with active, relapsing forms of MS.

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: To participate in the study, all the following inclusion criteria must be met: * Patients aged 18 years or older * Written informed consent obtained before participating in the study. * Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study. * Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab. * Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features). * Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion. Exclusion Criteria: To participate in the study, none of the following exclusion criteria must be met: * Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer. * Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.

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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

    10 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

    Amadora, 2720-276, Portugal

  • Novartis Investigative Site

    RECRUITING

    Guimarães, 4835-044, Portugal

  • Novartis Investigative Site

    RECRUITING

    Leiria, 2410-197, Portugal

  • Novartis Investigative Site

    RECRUITING

    Lisbon, 1169-050, Portugal

  • Novartis Investigative Site

    RECRUITING

    Lisbon, 1349-019, Portugal

  • Novartis Investigative Site

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    RECRUITING

    Matosinhos Municipality, 4454-513, Portugal

  • Novartis Investigative Site

    RECRUITING

    Ponte de Lima, 4990-041, Portugal

  • Novartis Investigative Site

    RECRUITING

    Porto, 4200 319, Portugal

  • Novartis Investigative Site

    RECRUITING

    Setúbal, 2910-549, Portugal

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