Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,945
- 主要终点
- To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
研究概览
简要总结
This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.
详细描述
PGRx is an information system that intends to bridge the resource gap to assess the effect of a drug on the risk of adverse events that are infrequent and/or with a long delay of onset. It uses some characteristics of the ad hoc case-control or case-referent design, transposed on a prospective, on-going, population-based recruitment plan. This particular design is called here systematic case-referent design in contrast to the ad hoc case-control or case-referent methodology. The PGRx information system is based on the routine and targeted recruitment of cases of a series of pathologies, compared to population-based referents for the study of exposure to a wide variety of drugs. Drug exposure ascertainment is obtained from two different sources in the PGRx.
system: A) A structured patient interview (telephone-administered questionnaire) B) The medical data form with the computerized medical prescriptions (interview guide)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
- •Age 14 to 79 years-old (included)
- •Patient residing in France
- •Patient accepting to participate in the study
- •Patient can read and respond to a telephone interview
排除标准
- •Prior reported history of the disease
- •Patient or Patient's parent cannot read the interview guide or answer a telephone interview questionnaire in French
- •Refusal to participate
结局指标
主要结局
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of myositis.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
时间窗: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
时间窗: At Month 36
次要结局
未报告次要终点