Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in a Multiple Sclerosis Patient Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Natalizumab Concentrations in Serum
研究概览
简要总结
Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri® serum levels.
详细描述
From a single site, consenting patients with relapsing forms of multiple sclerosis who are currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will be asked to provide blood samples on the same day, and prior to, a scheduled infusion of Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO) questionnaire along with the blood draws
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infusing with Tysabri at a single site, Rocky Mountain MS Clinic
排除标准
- •If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.
结局指标
主要结局
Natalizumab Concentrations in Serum
时间窗: 12 Months
Validate a novel peptide-based laboratory test enabling the measurement of nadir natalizumab (Tysabri®) serum levels in multiple sclerosis patients undergoing therapy compared to the traditional ELISA assay
次要结局
未报告次要终点
研究者
John F. Foley, MD
Principal Investigator
Rocky Mountain MS Research Group, LLC