NCT07235644Active, not recruiting
Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis
Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis: an Observational Study
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 184 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Uppsala University
- Diseases
- Multiple sclerosis
- NCT number
- NCT07235644
What you commit to
- Study type: Observational
- Planned participants: 184
- From 1 Jan 2025 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Switched to Rixathon® but later discontinued treatment within 3 months for reasons unrelated to disease activity (e.g., administrative, insurance, or non-medical reasons).
- Diagnosis of other major neurological diseases that could confound MS outcomes (e.g., stroke, CNS infection, or primary CNS tumors).
Other
- No recorded clinical follow-up visit after switching to Rixathon®.
- Participation in another interventional clinical trial affecting MS outcomes during the study period.
- Lack of consent for research use of data in the Swedish MS Registry.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.