NCT06310343已完成不适用
A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To quantify the longitudinal changes in alemtuzumab ADAs
研究概览
简要总结
The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period
详细描述
Primary To quantify the longitudinal changes in alemtuzumab ADAs over a 24 month period.
Secondary
- Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.
- Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions.
- Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
- Relative change in relapses or EDSS score based on alemtuzumab ADA levels.
- Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with RRMS who are being treated with alemtuzumab at Barts Health NHS Trust will be approached to participate in the study.
- •Patients must be willing and able to undergo blood tests.
排除标准
- •Ineligible for alemtuzumab under NHS England prescribing guidelines.
- •Those unable to comply with study requirements, including frequency of visits. Abnormal baseline investigations (WBC<3 x 10*9/l, lymphocytes <1.0 x 10*9/l, neutrophil count <1.5 x 10*9/l, platelet count <100 x 10*9/l, haemoglobin <110 g/l, LFT >/3x upper limit of normal of site reference ranges, potassium <2.8 mmol/l or >5.5 mmol/l, sodium /,125 mmol/l, creatinine >130 umol/l).
结局指标
主要结局
To quantify the longitudinal changes in alemtuzumab ADAs
时间窗: 2 years
次要结局
- 5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity.(2 years)
- 2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions.(2 years)
- 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.(2 years)
- 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels(2 years)
- 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.(1 year)
研究者
研究点 (1)
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