Switch to Ofatumumab and Level of Immunoglobulins
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 115
- 试验地点
- 1
研究概览
简要总结
This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up.
The primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.
详细描述
time perspective: retrospective and prospective
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years old) who had been treated with ocrelizumab for a relapsing form of Multiple Sclerosis according to the ocrelizumab marketing authorization (MA) treatment regimen for at least 18 months.
- •Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment*.
- •Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study*).
- •Patients agreeing to participate to the study.
- •Able to provide their non-opposition
- •At the discretion of the investigator, if a benefit for patients is expected based on their experience and depending on patient's characteristics
排除标准
- •Patients with ocrelizumab dose spacing > 8 months in the last 18 months before switch
- •Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch
- •Ongoing or planned pregnancy
研究组 & 干预措施
Ofatumumab
Adult patients (≥18 years) with relapsing multiple sclerosis treated with ocrelizumab for at least 18 months and already switched or switching from ocrelizumab to ofatumumab treatment
干预措施: ofatumumab (Drug)
结局指标
主要结局
未指定
次要结局
- Distribution of Fatigue Severity Scale (FSS) scores after switch to ofatumumab(24 months)
- Distribution of Multiple Sclerosis Functional Composite (MSFC) scores after switch to ofatumumab(24 months)
- Sex distribution (male/female, percentage of patients)(Baseline)
- Distribution of Expanded Disability Status Scale (EDSS) scores after switch to ofatumumab(24 months)