Hypogammaglobulinemia and Immunization Responses to Measles in Rituximab-treated Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Rate of hypogammaglobinemia
研究概览
简要总结
B cells are considered major contributors to multiple sclerosis (MS) pathogenesis, a role that has taken on renewed importance with the advent of B-cell-depleting therapies. Rituximab is being increasingly utilized as an off-label treatment option across MS patients .
In addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia and antibody deficiency across a variety of conditions including MS and related neuroinflammatory disorders.
Therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in rituximab-treated MS adult patients and to assess the correlation with vaccination response during the treatment.
详细描述
This is a prospective study which will be conducted in an educational medical hospitals in Sari, Iran.Adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and history of treatment with rituximab at least 3 times( 18 month) , enrolled to this study.Demographic patients' characteristics, including age, sex, vital sign, past medical history, drug history, will be recorded. Disease duration prior to rituximab, total rituximab dose, prior immunomodulatory drugs, Adverse drug reactions, the time interval between the last rituximab infusion and need for intravenous immunoglobulin replacement therapy and infections are recorded. Moreover, we will assess IgG and IgM levels, VZV titer at before rituximab administration and 6, 12, 18, months following the initiation of next dose of rituximab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of multiple sclerosis compatible with 2017 McDonald criteria
- •history of treatment with ritximab at least for 18 month
- •written informed consent
排除标准
- •history of IVIG intake in 3 past month
- •history of plasmapheresis in 3 past month
- •unknown vaccination history
- •any indication for concurrent use of immunomodulator or immunosuppressor drug
结局指标
主要结局
Rate of hypogammaglobinemia
时间窗: every 6 month until 18 month
serum IgG concentration lower than g/L,
次要结局
- type of infection(During 18 month of study)
- severity of hypogammaglobinemia(every 6 month until 18 month)
- immunization response to VZV vaccination(every 6 month until 18 month)
- severity of infection events(During 18 month of study)
- Rate of infection(during 18 month of fallow up)
研究者
Athena Sharifi Razavi
Assistant Professor in Nerology
Mazandaran University of Medical Sciences