Rituximab and Ocrelizumab in Serum With Multiple Sclerosis (ROS-MS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum drug concentration measured using liquid chromatography tandem mass spectrometry (LC-MS/MS)
研究概览
简要总结
ROS-MS is a clinical pharmacological substudy to the OVERLORD-MS study (NCT04578639), designed to examine the possibilities of personalized treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.
详细描述
OVERLORD-MS is a 30 months prospective randomized double blinded multicenter non-inferiority study. The objective of OVERLORD-MS is to demonstrate if rituximab is non-inferior to ocrelizumab with regards to efficacy and safety in treatment naïve patients with relapsing-remitting multiple sclerosis (RRMS), diagnosed within the last 12 months.
In the patients enrolled in the clinical pharmacological substudy ROS-MS the serum concentrations of rituximab and ocrelizumab will be quantified using liquid chromatography tandem mass spectrometry (LC MS/MS) at predefined points during the dosing interval. Relevant biochemical parameters will also be analyzed in these samples.
Based on these measurements, the investigators will examine correlations between serum concentrations, biochemical parameters and the clinical outcomes in the OVERLORD-MS study. The objective is to evaluate whether clinical pharmacological tools, such as therapeutic drug monitoring (TDM) and pharmacokinetic pharmacodynamic models (PK-PD models), may be of value in the personalization of treatment with rituximab and ocrelizumab in patients with relapsing-remitting multiple sclerosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included in OVERLORD-MS (NCT04578639)
- •Willing to attend laboratory for blood sample collection at scheduled time points
- •Exclusion criteria:
- •* Not willing to attend laboratory for blood sample collection at scheduled time points
排除标准
- 未提供
结局指标
主要结局
Serum drug concentration measured using liquid chromatography tandem mass spectrometry (LC-MS/MS)
时间窗: Up to 24 weeks (during one cycle of treatment, injection of rituximab or ocrelizumab is scheduled every 6 months)
The serum concentration of rituximab or ocrelizumab after drug infusion (maximum serum concentration (Cmax)) and 2, 4, 8, 12, 24 weeks thereafter.
次要结局
未报告次要终点