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

NCT07235644

Active Not RecruitingN/A

Sponsor: Uppsala University

Conditions: MS (Multiple Sclerosis), Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (Relapsing Remitting)

Countries: Sweden

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 overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Uppsala, Sweden