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

NCT07235644 | Active Not Recruiting

• 1 other identifier: 2024-08358-01
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MS (Multiple Sclerosis); Multiple Sclerosis (MS) - Relapsing-remitting; Multiple Sclerosis (Relapsing Remitting)

Keywords

Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Progressive Multiple Sclerosis; Rituximab; MabThera; Rixathon; Biosimilar; B-cell depletion; Neurofilament light chain (pNfL); MRI lesions; Disease progression; Disability progression; Expanded Disability Status Scale (EDSS); No Evidence of Disease Activity (NEDA); Quantitative MRI (qMRI); SyMRI; Plasma biomarkers; Observational Study; Retrospective Study; Treatment switch; Real-world evidence

Outcome Measures

Primary Outcomes (1)

• Change in plasma neurofilament light chain (pNfL) levels before and after switching from MabThera® to Rixathon®

  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.

  From the first available pNfL measurement (starting early 2022) to the time of data extraction in spring 2025

Secondary Outcomes (5)

• Change in number of new T2 lesions on brain MRI before and after switching from MabThera® to Rixathon®

  From earliest available MRI scans (starting in 2017) to the time of data extraction in spring 2025.

• Change in annualized relapse rate before and after switching from MabThera® to Rixathon®

  From earliest available clinical data (several years prior to 2023) to the time of data extraction in spring 2025.

• Change in disability progression measured by Expanded Disability Status Scale (EDSS) before and after switching from MabThera® to Rixathon®

  From earliest available EDSS measurements (several years prior to 2023) to the time of data extraction in spring 2025.

• Proportion of participants maintaining No Evidence of Disease Activity (NEDA) before and after switching from MabThera® to Rixathon®

  From earliest available clinical and MRI data (several years prior to 2023) to the time of data extraction in spring 2025.

• Frequency of serious adverse events (Grade 3-5) after switching from MabThera® to Rixathon®

  From the date of switching to Rixathon® (January 2023) to the time of data extraction in spring 2025.

Other Outcomes (1)

• Change in quantitative MRI (qMRI) metrics using SyMRI before and after switching from MabThera® to Rixathon®

  From earliest available SyMRI scans (starting in 2017) to the time of data extraction in spring 2025.

Study Arms (1)

MS patients switched from MabThera® to Rixathon®

This cohort includes people with multiple sclerosis (MS) who were treated with MabThera® at Uppsala University Hospital and switched to Rixathon® starting January 2023 as part of routine clinical care. Participants were followed through standard clinical visits, blood tests, and MRI scans. Health outcomes before and after the switch will be compared using retrospective data from the Swedish MS Registry (SMSreg).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (10)

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  PMID: 30644981 BACKGROUND

• Lizak N, Lugaresi A, Alroughani R, Lechner-Scott J, Slee M, Havrdova E, Horakova D, Trojano M, Izquierdo G, Duquette P, Girard M, Prat A, Grammond P, Hupperts R, Grand'Maison F, Sola P, Pucci E, Bergamaschi R, Oreja-Guevara C, Van Pesch V, Ramo C, Spitaleri D, Iuliano G, Boz C, Granella F, Olascoaga J, Verheul F, Rozsa C, Cristiano E, Flechter S, Hodgkinson S, Amato MP, Deri N, Jokubaitis V, Spelman T, Butzkueven H, Kalincik T; MSBase Study Group. Highly active immunomodulatory therapy ameliorates accumulation of disability in moderately advanced and advanced multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Mar;88(3):196-203. doi: 10.1136/jnnp-2016-313976. Epub 2016 Sep 28.

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MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Charcot-Marie-Tooth disease, Type 1F; Disease Progression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joachim Burman, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data set will be stored for 15 years
• Access Criteria: Study protocol will be made available upon request. Access to study data will be decided after contact with the study principal investigator. All access should be of scientific purposes.

Locations

SE (1)