The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria.
研究概览
简要总结
An open labelled trial of Kineret (anakinra) induction therapy (100mg./day) in over a four week period in the treatment of Familial Cold Urticaria.
Familial Cold Urticaria (FCU) is a rare autosomal dominant condition manifesting symptoms triggered by exposure to cold and variable in expression. Currently there is no standard reliable agent available for the treatment of patients with FCU.This study will evaluate the efficacy of Kineret (anakinra), an interleukin 1 receptor antagonist in induction and maintenance therapy in patients with FCU.
详细描述
Product: Kineret (anakinra) Protocol title: The Use of Kineret (anakinra) in the Treatment of Familial Cold Urticaria (FCU) Target Disease: Familial Cold Urticaria Patients: 8 patients all previously diagnosed with FCU and living close to Moncton, N.B.
Study Objectives:
- To assess the efficacy of Kineret (anakinra) 100mg. given subcutaneously daily in subjects with FCU.
- To demonstrate the use of CRP and SAA as objective laboratory markers of the effectiveness of treatment.
- To determine the effect of Kineret (anakinra)on the quality of life of patients with FCU.
Study design: An open-labelled trial of Kineret (anakinra) induction therapy (100mg./day) over a four week period.
Treatment regimens: After initial clinical and laboratory assessment, the patients will receive Kineret (anakinra) 100mg. daily for four weeks. They will be observed for two further weeks without the medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must be 18 years of age or older at the time of enrollment; may be male or female
- •Must be previously diagnosed with Familial Cold Urticaria (FCU)
- •Must react with at least one of the symptoms of FCU in the summer months at least four times per week sufficiently to interfere with ordinary daily activities or inhibit normal life enjoyment.
- •Women must be willing to have a pregnancy test and if necessary, use contraceptive measures.
排除标准
- •Receiving any systemic medications/treatments that could affect FCU.
- •Pregnancy, nursing or planning pregnancy, or, have recently been pregnant to less than three months development and with a history of serious birth defect.
- •Have had any previous treatment with Kineret (anakinra) or any therapeutic agent targeted at IL-1 blockade.
- •Have used any investigational drug within the previous 1 month or five times the half life of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half life.
- •Have received any systemic medication or treatments that could affect the symptoms of FCU such as antihistamines, corticosteroid drugs, NSAIDS, anabolic medications or Ketotifen within 2 weeks of the baseline visit.
- •Have any known malignancy or have a history of malignancy within the previous five years (with the exception of basal or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence).
结局指标
主要结局
To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria.
时间窗: Eight weeks
次要结局
- To demonstrate the use of C-Reactive Protein (CRP) and Serum Amyloid A Protein (SAA) levels as objective laboratory indicators of effective treatment and to compare the results of two different laboratory methods for the estimation of CRP(Eight weeks)