MS (Multiple Sclerosis)NCT07235644
Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis
An observational study of MS (Multiple Sclerosis) and Multiple Sclerosis (MS) - Relapsing-remitting, run by Uppsala University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MS (Multiple Sclerosis), Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (Relapsing Remitting)
- How many people
- 184 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis: an Observational Study
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:
Read more
- 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.
Read the detailed description
This is a retrospective observational study conducted at Uppsala University Hospital. The study aims to evaluate the efficacy and safety of switching from MabThera® (rituximab originator) to Rixathon® (rituximab biosimilar) in people with multiple sclerosis (MS), specifically those diagnosed with relapsing-remitting MS (RRMS) and progressive MS.
Starting in January 2023, the Department of Neurology at Uppsala University Hospital made an administrative decision to move from using rituximab (MabThera®) to rituximab (Rixathon®) in the treatment of MS, primarily for cost-saving reasons. This study will retrospectively analyze clinical and radiological outcomes collected before and after the switch. Data will be extracted from the Swedish MS Registry (SMSreg), a national database containing clinical information on people with MS across Sweden. Only patients treated at Uppsala University Hospital are included.
The primary objective of the study is to determine whether switching to Rixathon® affects disease activity, as measured by changes in plasma neurofilament light (pNfL) concentrations. pNfL is a biomarker of neuroaxonal damage, and elevated levels are associated with ongoing inflammation and neurodegeneration in MS.
Secondary objectives include comparing:
- The number of new T2 lesions on brain MRI scans before and after the switch
- The annualized relapse rate before and after the switch
- Changes in disability progression, measured by the Expanded Disability Status Scale (EDSS)
- Proportion of participants maintaining "No Evidence of Disease Activity" (NEDA) status
- Occurrence of serious adverse events (Grade 3-5 according to CTCAE v5.0)
Exploratory analyses will incorporate quantitative MRI (qMRI) metrics, including brain parenchymal fraction (BPF), myelin correlated fraction (MyCPF), myelin correlated volume (MyC), cerebrospinal fluid (CSF) volume, brain parenchymal volume (BPV), and intracranial volume. These parameters are obtained from SyMRI sequences that have been part of standard clinical practice at Uppsala University Hospital since 2017.
Participants eligible for inclusion were already being treated with MabThera® at the end of 2022 and completed the switch to Rixathon®. These individuals have been followed through routine clinical care with yearly MRI scans, regular EDSS assessments, and quarterly pNfL blood testing.
Data Quality Assurance:
Data will be obtained directly from SMSreg, which ensures quality through national standard operating procedures, regular audits, and predefined data validation rules. The registry will be vetted against clinical source documentation in the electronic medical records. Variables such as MRI findings, pNfL levels, relapse events, and EDSS scores are standardized across Sweden. No additional site-specific audits are planned beyond the SMSreg's internal quality controls.
Handling Missing Data:
In case of missing or inconsistent data points, standard imputation methods will be used as outlined in the analysis plan. For missing values that cannot be resolved, sensitivity analyses will be performed to assess the impact on results.
Sample Size and Power Considerations:
At the time of the medication switch, 184 MS patients were being treated with rituximab at the Department of Neurology. Given this sample size and historical relapse rates in RRMS, the study is adequately powered to detect meaningful differences in clinical and biomarker outcomes pre- and post-switch.
Statistical Analysis Plan:
The primary analysis will use a mixed-model repeated measures ANOVA to compare pNfL levels before and after the switch. Secondary outcomes (MRI activity, relapse rates, EDSS scores, NEDA status, and adverse events) will be analyzed using appropriate methods, including paired t-tests, Wilcoxon signed-rank tests, or McNemar's test, depending on the data distribution. Subgroup analyses will be performed separately for participants with RRMS and progressive MS. All analyses will adjust for potential confounders such as age, sex, disease duration, and prior treatment history.
This study will provide critical real-world evidence on whether switching to a rituximab biosimilar affects clinical outcomes and disease progression in MS.
- 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
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Charcot-Marie-Tooth disease, Type 1F, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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®
Brain MRI scans will be used to assess new T2 lesions, a marker of disease activity in multiple sclerosis. Researchers will compare the number of new T2 lesions identified on MRI before and after switching treatments to evaluate the impact of the switch on radiological disease activity.
Measured: 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®
Relapse is defined as new or worsening neurological symptoms lasting at least 24 hours without external causes (such as fever or infection). Researchers will compare the annualized relapse rate before and after switching to assess the effect of the treatment change.
Measured: 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®
Disability progression will be evaluated using EDSS scores, a standardized method to quantify disability in MS. Researchers will compare EDSS scores to assess whether the treatment switch affects long-term disability progression.
Measured: 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®
NEDA is defined as absence of relapses, absence of new MRI lesions, and no confirmed disability worsening. Researchers will compare the proportion of participants maintaining NEDA status before and after the treatment switch.
Measured: 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®
Serious adverse events will be recorded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Events graded 3-5 will be compared after the switch to evaluate safety outcomes associated with Rixathon® use.
Measured: From the date of switching to Rixathon® (January 2023) to the time of data extraction in spring 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jan 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MS (Multiple Sclerosis)Studies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim Burman, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235644
- Sponsor's protocol ID
- 2024-08358-01
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be made available upon request.
Publications
Simren J, Andreasson U, Gobom J, Suarez Calvet M, Borroni B, Gillberg C, Nyberg L, Ghidoni R, Fernell E, Johnson M, Depypere H, Hansson C, Jonsdottir IH, Zetterberg H, Blennow K. Establishment of reference values for plasma neurofilament light based on healthy individuals aged 5-90 years. Brain Commun. 2022 Jul 4;4(4):fcac174. doi: 10.1093/braincomms/fcac174. eCollection 2022.
PubMed 35865350McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012 Mar;91(3):405-17. doi: 10.1038/clpt.2011.343. Epub 2012 Feb 8.
PubMed 22318617Ventola CL. Biosimilars: part 1: proposed regulatory criteria for FDA approval. P T. 2013 May;38(5):270-87.
PubMed 23946620Calo-Fernandez B, Martinez-Hurtado JL. Biosimilars: company strategies to capture value from the biologics market. Pharmaceuticals (Basel). 2012 Dec 12;5(12):1393-408. doi: 10.3390/ph5121393.
PubMed 24281342Simoens S, Verbeken G, Huys I. Biosimilars and market access: a question of comparability and costs? Target Oncol. 2012 Dec;7(4):227-31. doi: 10.1007/s11523-011-0192-7. Epub 2012 Jan 17.
PubMed 22249657Hauser SL, Waubant E, Arnold DL, Vollmer T, Antel J, Fox RJ, Bar-Or A, Panzara M, Sarkar N, Agarwal S, Langer-Gould A, Smith CH; HERMES Trial Group. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med. 2008 Feb 14;358(7):676-88. doi: 10.1056/NEJMoa0706383.
PubMed 18272891Svenningsson A, Frisell T, Burman J, Salzer J, Fink K, Hallberg S, Hambraeus J, Axelsson M, Nimer FA, Sundstrom P, Gunnarsson M, Johansson R, Mellergard J, Rosenstein I, Ayad A, Sjoblom I, Risedal A, de Flon P, Gilland E, Lindeberg J, Shawket F, Piehl F, Lycke J. Safety and efficacy of rituximab versus dimethyl fumarate in patients with relapsing-remitting multiple sclerosis or clinically isolated syndrome in Sweden: a rater-blinded, phase 3, randomised controlled trial. Lancet Neurol. 2022 Aug;21(8):693-703. doi: 10.1016/S1474-4422(22)00209-5.
PubMed 35841908Brown JWL, Coles A, Horakova D, Havrdova E, Izquierdo G, Prat A, Girard M, Duquette P, Trojano M, Lugaresi A, Bergamaschi R, Grammond P, Alroughani R, Hupperts R, McCombe P, Van Pesch V, Sola P, Ferraro D, Grand'Maison F, Terzi M, Lechner-Scott J, Flechter S, Slee M, Shaygannejad V, Pucci E, Granella F, Jokubaitis V, Willis M, Rice C, Scolding N, Wilkins A, Pearson OR, Ziemssen T, Hutchinson M, Harding K, Jones J, McGuigan C, Butzkueven H, Kalincik T, Robertson N; MSBase Study Group. Association of Initial Disease-Modifying Therapy With Later Conversion to Secondary Progressive Multiple Sclerosis. JAMA. 2019 Jan 15;321(2):175-187. doi: 10.1001/jama.2018.20588.
PubMed 30644981Lizak 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.
PubMed 27683916Capra R, Cordioli C, Rasia S, Gallo F, Signori A, Sormani MP. Assessing long-term prognosis improvement as a consequence of treatment pattern changes in MS. Mult Scler. 2017 Nov;23(13):1757-1761. doi: 10.1177/1352458516687402. Epub 2017 Jan 12.
PubMed 28080255
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis: an Observational Study
- ClinicalTrials.gov ID
- NCT07235644
- Acronym / sponsor ID
- 2024-08358-01
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective observational study conducted at Uppsala University Hospital. The study aims to evaluate the efficacy and safety of switching from MabThera® (rituximab originator) to Rixathon® (rituximab biosimilar) in people with multiple sclerosis (MS), specifically those diagnosed with relapsing-remitting MS (RRMS) and progressive MS.
Starting in January 2023, the Department of Neurology at Uppsala University Hospital made an administrative decision to move from using rituximab (MabThera®) to rituximab (Rixathon®) in the treatment of MS, primarily for cost-saving reasons. This study will retrospectively analyze clinical and radiological outcomes collected before and after the switch. Data will be extracted from the Swedish MS Registry (SMSreg), a national database containing clinical information on people with MS across Sweden. Only patients treated at Uppsala University Hospital are included.
The primary objective of the study is to determine whether switching to Rixathon® affects disease activity, as measured by changes in plasma neurofilament light (pNfL) concentrations. pNfL is a biomarker of neuroaxonal damage, and elevated levels are associated with ongoing inflammation and neurodegeneration in MS.
Secondary objectives include comparing:
- The number of new T2 lesions on brain MRI scans before and after the switch
- The annualized relapse rate before and after the switch
- Changes in disability progression, measured by the Expanded Disability Status Scale (EDSS)
- Proportion of participants maintaining "No Evidence of Disease Activity" (NEDA) status
- Occurrence of serious adverse events (Grade 3-5 according to CTCAE v5.0)
Exploratory analyses will incorporate quantitative MRI (qMRI) metrics, including brain parenchymal fraction (BPF), myelin correlated fraction (MyCPF), myelin correlated volume (MyC), cerebrospinal fluid (CSF) volume, brain parenchymal volume (BPV), and intracranial volume. These parameters are obtained from SyMRI sequences that have been part of standard clinical practice at Uppsala University Hospital since 2017.
Participants eligible for inclusion were already being treated with MabThera® at the end of 2022 and completed the switch to Rixathon®. These individuals have been followed through routine clinical care with yearly MRI scans, regular EDSS assessments, and quarterly pNfL blood testing.
Data Quality Assurance:
Data will be obtained directly from SMSreg, which ensures quality through national standard operating procedures, regular audits, and predefined data validation rules. The registry will be vetted against clinical source documentation in the electronic medical records. Variables such as MRI findings, pNfL levels, relapse events, and EDSS scores are standardized across Sweden. No additional site-specific audits are planned beyond the SMSreg's internal quality controls.
Handling Missing Data:
In case of missing or inconsistent data points, standard imputation methods will be used as outlined in the analysis plan. For missing values that cannot be resolved, sensitivity analyses will be performed to assess the impact on results.
Sample Size and Power Considerations:
At the time of the medication switch, 184 MS patients were being treated with rituximab at the Department of Neurology. Given this sample size and historical relapse rates in RRMS, the study is adequately powered to detect meaningful differences in clinical and biomarker outcomes pre- and post-switch.
Statistical Analysis Plan:
The primary analysis will use a mixed-model repeated measures ANOVA to compare pNfL levels before and after the switch. Secondary outcomes (MRI activity, relapse rates, EDSS scores, NEDA status, and adverse events) will be analyzed using appropriate methods, including paired t-tests, Wilcoxon signed-rank tests, or McNemar's test, depending on the data distribution. Subgroup analyses will be performed separately for participants with RRMS and progressive MS. All analyses will adjust for potential confounders such as age, sex, disease duration, and prior treatment history.
This study will provide critical real-world evidence on whether switching to a rituximab biosimilar affects clinical outcomes and disease progression in MS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in plasma neurofilament light chain (pNfL) levels before and after switching from MabThera® to Rixathon®
Time frame: 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.
5 secondary outcomes
Change in number of new T2 lesions on brain MRI before and after switching from MabThera® to Rixathon®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: From the date of switching to Rixathon® (January 2023) to the time of data extraction in spring 2025.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 35865350Simren J, Andreasson U, Gobom J, Suarez Calvet M, Borroni B, Gillberg C, Nyberg L, Ghidoni R, Fernell E, Johnson M, Depypere H, Hansson C, Jonsdottir IH, Zetterberg H, Blennow K. Establishment of reference values for plasma neurofilament light based on healthy individuals aged 5-90 years. Brain Commun. 2022 Jul 4;4(4):fcac174. doi: 10.1093/braincomms/fcac174. eCollection 2022.
- Background: PubMed 22318617McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012 Mar;91(3):405-17. doi: 10.1038/clpt.2011.343. Epub 2012 Feb 8.
- Background: PubMed 23946620Ventola CL. Biosimilars: part 1: proposed regulatory criteria for FDA approval. P T. 2013 May;38(5):270-87.
- Background: PubMed 24281342Calo-Fernandez B, Martinez-Hurtado JL. Biosimilars: company strategies to capture value from the biologics market. Pharmaceuticals (Basel). 2012 Dec 12;5(12):1393-408. doi: 10.3390/ph5121393.
- Background: PubMed 22249657Simoens S, Verbeken G, Huys I. Biosimilars and market access: a question of comparability and costs? Target Oncol. 2012 Dec;7(4):227-31. doi: 10.1007/s11523-011-0192-7. Epub 2012 Jan 17.
- Background: PubMed 18272891Hauser SL, Waubant E, Arnold DL, Vollmer T, Antel J, Fox RJ, Bar-Or A, Panzara M, Sarkar N, Agarwal S, Langer-Gould A, Smith CH; HERMES Trial Group. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med. 2008 Feb 14;358(7):676-88. doi: 10.1056/NEJMoa0706383.
- Background: PubMed 35841908Svenningsson A, Frisell T, Burman J, Salzer J, Fink K, Hallberg S, Hambraeus J, Axelsson M, Nimer FA, Sundstrom P, Gunnarsson M, Johansson R, Mellergard J, Rosenstein I, Ayad A, Sjoblom I, Risedal A, de Flon P, Gilland E, Lindeberg J, Shawket F, Piehl F, Lycke J. Safety and efficacy of rituximab versus dimethyl fumarate in patients with relapsing-remitting multiple sclerosis or clinically isolated syndrome in Sweden: a rater-blinded, phase 3, randomised controlled trial. Lancet Neurol. 2022 Aug;21(8):693-703. doi: 10.1016/S1474-4422(22)00209-5.
- Background: PubMed 30644981Brown JWL, Coles A, Horakova D, Havrdova E, Izquierdo G, Prat A, Girard M, Duquette P, Trojano M, Lugaresi A, Bergamaschi R, Grammond P, Alroughani R, Hupperts R, McCombe P, Van Pesch V, Sola P, Ferraro D, Grand'Maison F, Terzi M, Lechner-Scott J, Flechter S, Slee M, Shaygannejad V, Pucci E, Granella F, Jokubaitis V, Willis M, Rice C, Scolding N, Wilkins A, Pearson OR, Ziemssen T, Hutchinson M, Harding K, Jones J, McGuigan C, Butzkueven H, Kalincik T, Robertson N; MSBase Study Group. Association of Initial Disease-Modifying Therapy With Later Conversion to Secondary Progressive Multiple Sclerosis. JAMA. 2019 Jan 15;321(2):175-187. doi: 10.1001/jama.2018.20588.
- Background: PubMed 27683916Lizak 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.
- Background: PubMed 28080255Capra R, Cordioli C, Rasia S, Gallo F, Signori A, Sormani MP. Assessing long-term prognosis improvement as a consequence of treatment pattern changes in MS. Mult Scler. 2017 Nov;23(13):1757-1761. doi: 10.1177/1352458516687402. Epub 2017 Jan 12.
- Individual participant dataSharing planned: Yes. Study protocol will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Burman, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MS (Multiple Sclerosis) and Multiple Sclerosis (MS) - Relapsing-remitting, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma neurofilament light chain (pNfL) levels before and after switching from MabThera® to Rixathon® (time frame: From the first available pNfL measurement (starting early 2022) to the time of data extraction in spring 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07235644, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.