An Open, Uncontrolled, Non-interventional Observational Cohort Outcome Study of Immunoglobulins in 3 Indications: Primary and Secondary Immunodeficiencies and Neurological Auto-immune Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 685
- 试验地点
- 7
- 主要终点
- Immunoglobulin IgG dosage
研究概览
简要总结
This non-interventional, epidemiological study assesses long-term outcomes in subjects receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen prescribed by the treating physician, under routine clinical conditions in Germany.
Long-term outcome data are collected on patient characteristics in the various indications, drug utilization of intravenous and subcutaneous IgG (e.g. treatment and dosing patterns), effectiveness (i.e. number of infections), tolerability, health related quality of life, and economic variables (number of hospitalizations, sick-leave days etc.) with the possibility to estimate direct costs.
详细描述
In view of the broad range of indications in immunodeficiency and immunomodulation, it is of interest to document the use of IgG under the conditions of everyday practice and to analyze the endpoints (outcomes). A prospective cohort study such as this is an important evidence source for such rare diseases as those mentioned above. The aim of this outcome study is to fill the gap of the lack of long-term data in these rare diseases treated with IgG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either gender with primary, severe secondary immunodeficiency and recurrent infections or neurological autoimmune diseases
- •Naïve to IgG, or pre-treated with IgG
- •Subject or parent/legally authorized representative has provided written informed consent.
排除标准
- 未提供
结局指标
主要结局
Immunoglobulin IgG dosage
时间窗: up to 54 months
Dosage of immunoglobulins (IgG); frequency of IgG administrations; days of treatment with IgG; duration of infusion of IgG.
次要结局
- Infection rate(up to 54 months)
- Health-related quality of life(up to 54 months)
- Neurological and muscular function (for neurological auto-immune diseases only)(up to 54 months)
- Duration of manifest auto-immune disease within the follow-up period(for neurological auto-immune diseases only).(up to 54 months)
- Pharmacoeconomic parameters(up to 54 months)