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O estudo clínico NCT07235644 para EM (Esclerose Múltipla), Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (Relapsing Remitting) está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Universidade de UppsalaComparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis 184 Observacional
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O estudo clínico NCT07235644 é um estudo observacional para EM (Esclerose Múltipla), Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (Relapsing Remitting). Seu status atual é: ativo, não recrutando. O estudo começou em 1 de janeiro de 2025 e pretende incluir 184 participantes. Coordenado por a Universidade de Uppsala e deve ser concluído em 30 de dezembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de novembro de 2025.
Resumo
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 disabil...
Descrição detalhada
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 Univer...
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Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis: an Observational Study
Condições médicas
EM (Esclerose Múltipla)Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (Relapsing Remitting)Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- 2024-08358-01
Número NCT
Data de início (real)
2025-01-01
Última atualização postada
2025-11-19
Data de conclusão (estimada)
2025-12-30
Inscrição (estimada)
184
Tipo de estudo
Observacional
Status
Ativo, não recrutando
Palavras-chave
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
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
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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). | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. | 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. | 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. | 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. | 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. | From the date of switching to Rixathon® (January 2023) to the time of data extraction in spring 2025. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Sexos elegíveis
Todos
- 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.
- 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.
Universidade de UppsalaSem dados de contato.
1 Locais do estudo em 1 países
Uppsala University Hospital, Uppsala, Sweden