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MS patients switch meds: will a cheaper option work just as well?

NCT ID NCT07235644

Disease control Sponsor: Uppsala University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at people with relapsing-remitting multiple sclerosis who switched from the drug MabThera to a similar, lower-cost medicine called Rixathon. Researchers want to see if the switch changes signs of nerve damage, new brain lesions, relapses, or disability. They will review medical records from 184 patients at Uppsala University Hospital to compare health data before and after the switch.

What this could mean

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

Active substance
Rituximab (biosimilar Rixathon)
What this could lead to
If successful, this study could show that switching to a cheaper biosimilar is just as safe and effective, potentially lowering treatment costs for MS patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It only looks at a small group at one hospital, so findings may not apply to everyone.

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 184 people

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

Started

Jan 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be selected from people with multiple sclerosis (MS) treated at the Department of Neurology, Uppsala University Hospital, Sweden. All participants were registered in the Swedish MS Registry (SMSreg) and received MabThera® (rituximab originator) before switching to Rixathon® (rituximab biosimilar) as part of routine clinical care starting January 2023. The population includes individuals with relapsing-remitting MS and progressive MS who have available clinical follow-up data, blood biomarker measurements, and brain MRI scans.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Diagnosed with multiple sclerosis (MS) according to the 2017 McDonald criteria (or previous applicable versions at the time of diagnosis). * Treated with MabThera® (rituximab originator) at the Department of Neurology, Uppsala University Hospital before January 1, 2023. * Switched to Rixathon® (rituximab biosimilar) for MS treatment starting January 1, 2023. * Registered in the Swedish MS Registry (SMSreg) with available clinical data. * At least one clinical follow-up visit recorded before the switch and one after the switch. * Available plasma neurofilament light chain (pNfL) measurement and/or brain MRI scan during the study period. Exclusion Criteria: * No recorded clinical follow-up visit after switching to Rixathon®. * Switched to Rixathon® but later discontinued treatment within 3 months for reasons unrelated to disease activity (e.g., administrative, insurance, or non-medical reasons). * Participation in another interventional clinical trial affecting MS outcomes during the study period. * Diagnosis of other major neurological diseases that could confound MS outcomes (e.g., stroke, CNS infection, or primary CNS tumors). * Lack of consent for research use of data in the Swedish MS Registry.

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Conditions

The condition(s) this trial relates to.

Charcot-Marie-Tooth disease type 1F chronic progressive multiple sclerosis Disease Progression multiple sclerosis myeloid sarcoma relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MS (multiple sclerosis) Multiple sclerosis (MS) - relapsing-remitting Multiple sclerosis, relapsing-remitting

Contacts and locations

Locations

  • Uppsala University Hospital

    Uppsala, Sweden

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