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Can Real-World data show how well multiple sclerosis patients stick with ofatumumab?

NCT ID NCT07821411

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are studying how people with relapsing multiple sclerosis use ofatumumab in everyday practice in Germany and Japan. The study looks at insurance claims from about 5,000 adults to see how many stay on the treatment and how regularly they take it. It also tracks how often patients switch to other medicines and which treatments they try before or after ofatumumab. The goal is to understand real-world treatment patterns, not to test whether the drug works in a controlled experiment.

What this could mean

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

Active substance
ofatumumab, a multiple sclerosis medicine given as an injection
What this could lead to
If the data show strong persistence and adherence, doctors could gain confidence in how ofatumumab performs outside clinical trials. It may also help identify which patients are most likely to stay on treatment.
What could go wrong
This is an observational study using insurance claims, so it cannot prove that ofatumumab causes any particular outcome. Claims data may miss reasons why people stop or switch treatment, and the findings may not apply to other countries or health systems.

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 5,000 people

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

Started

Jul 2026

Expected to finish

Sep 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

Adult RMS patients who start new treatment with OMB or a DMT.

Ages

18 to 100 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: Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria: * Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS). * Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT). * Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period. * Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death). Exclusion criteria: Patients will be excluded if they meet any of the following criteria: * Have inactive SPMS or primary progressive multiple sclerosis (PPMS). * Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis secondary progressive 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

    Basel, CH-4056, Switzerland

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