Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-… (NCT07235644) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis
Sweden184 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in plasma neurofilament light chain (pNfL) levels before and after switching from MabThera® to Rixathon®
Timeframe: From the first available pNfL measurement (starting early 2022) to the time of data extraction in spring 2025