Comparison of Efficacy and Safety in Patients Switching From MabThera® to Rixathon® in Relapsing-Remitting Multiple Sclerosis: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Change in plasma neurofilament light chain (pNfL) levels before and after switching from MabThera® to Rixathon®
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •Switched to Rixathon® (rituximab biosimilar) for MS treatment starting January 1,
- •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.
排除标准
- •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.
结局指标
主要结局
Change in plasma neurofilament light chain (pNfL) levels before and after switching from MabThera® to Rixathon®
时间窗: 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.
次要结局
- 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.)