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Real-world MS drug study tracks relapse reduction in italian patients

NCT ID NCT06345157

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well ofatumumab (Kesimpta®) works for people with relapsing-remitting multiple sclerosis (RRMS) in real-life settings across Italy. About 379 adults already prescribed the drug will be followed for 12 months to measure relapse rates and thinking speed. The goal is to see if the benefits seen in clinical trials hold up outside of a controlled environment.

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

379 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jun 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

300 RRMS patients newly treated with ofatumumab.

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. Male or female outpatients ≥18 years old. 2. Patients diagnosed with RRMS (McDonald criteria 2017). 3. Patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the SmPC and to AIFA reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment). 4. Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed. Exclusion Criteria: 1. Patients outside the approved label of ofatumumab. 2. Pregnant and lactating women. 3. Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement. 4. Patients cannot participate in this non-interventional study if they also participate in an interventional trial. 5. Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.

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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, relapsing-remitting

Contacts and locations

Locations

  • Novartis Investigative Site

    Ancona, AN, 60126, Italy

  • Novartis Investigative Site

    L’Aquila, AQ, 67100, Italy

  • Novartis Investigative Site

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    Chieti, CH, 66100, Italy

  • Novartis Investigative Site

    Catania, CT, 95123, Italy

  • Novartis Investigative Site

    Catanzaro, CZ, 88100, Italy

  • Novartis Investigative Site

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    Foggia, FG, 71122, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Pozzilli, IS, 86077, Italy

  • Novartis Investigative Site

    Monza, MB, 20900, Italy

  • Novartis Investigative Site

    Palermo, PA, 90127, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Ravenna, RA, 48100, Italy

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Roma, RM, 00189, Italy

  • Novartis Investigative Site

    Siena, SI, 53100, Italy

  • Novartis Investigative Site

    Sassari, SS, 07100, Italy

  • Novartis Investigative Site

    Trento, TN, 38122, Italy

  • Novartis Investigative Site

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Treviso, TV, 31100, Italy

  • Novartis Investigative Site

    Udine, UD, 33100, Italy

  • Novartis Investigative Site

    Gallarate, VA, 21013, Italy

  • Novartis Investigative Site

    Vicenza, VI, 36100, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Naples, 80138, Italy

  • Novartis Investigative Site

    Novara, 28100, Italy

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