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Clinical Trials in Sweden / NCT07235644
Active, not recruiting Observational

Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis

NCT07235644 · tracked via the Priya Life Science Sweden tracker
Sponsor
Uppsala University
Phase
Observational
Started
2025-01-01
Last updated
2025-11-19

Condition(s) studied

MS (Multiple Sclerosis)Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (Relapsing Remitting)

Study summary

This observational study investigates if switching from MabThera® to Rixathon® is associated with changes in disease activity and/or safety in people with multiple sclerosis (MS).

The main questions it aims to answer are:

* Does switching to Rixathon® affect tissue damage, measured by blood levels of neurofilament light (pNfL)?
* Does switching to Rixathon® affect the number of new MRI lesions, relapses, or disability progression?

Researchers will look at health information already collected from participants before and after the medication switch. Participants include people with MS treated at Uppsala University Hospital who switched from MabThera® to Rixathon® starting in January 2023. Researchers will use data from regular clinical visits, blood tests, brain MRI scans, and disability scores (EDSS) recorded in the Swedish MS Registry.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in plasma neurofilament light chain (pNfL) levels before and after switching from MabThera® to Rixathon® — From the first available pNfL measurement (starting early 2022) to the time of data extraction in spring 2025
    Plasma neurofilament light chain (pNfL) is a blood biomarker that reflects nerve cell injury and disease activity in multiple sclerosis. Researchers will measure and compare pNfL levels collected before and after switching treatments to evaluate whether the switch influences underlying tissue damage. All available pNfL measurements from routine clinical practice will be used.

Trial sites (1)

FacilityCityRegionStatus
Uppsala University Hospital Uppsala Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07235644 on ClinicalTrials.gov ↗ ← All trials in Sweden