NCT04583475已完成不适用
Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2021年2月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Proportion of patients benefiting from an intensification of OMA treatment at 3 months,
研究概览
简要总结
This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patient having expressed non-opposition
- •Affiliation to a social protection scheme (beneficiary or entitled person)
- •Decision by the investigator to initiate, independently of the study, an AOM treatment for Spontaneous Chronic Urticaria that may or may not be associated with an inducible component.
排除标准
- •Patients < 18 years of age
- •Patient who had previously received AOM treatment prior to the inclusion visit
- •Patients under guardianship or curatorship
- •Pregnant or breastfeeding woman
结局指标
主要结局
Proportion of patients benefiting from an intensification of OMA treatment at 3 months,
时间窗: At 3 months
defined as an increase in dose (more than 300mg) and/or a reduction in the administration interval to less than 4 weeks.
次要结局
- Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects.(at baseline)
- Proportion of patients benefiting from an intensification of OMA treatment(Baseline, at 6 months and at 9 months)
- Proportion of patients with side effect during follow-up (number and percentage of the total patients)(at 3, 6 and 9 months)
- Life Quality(at 3, 6 and 9 months)
- Activity of urticaria (score UCT) composite(at 3, 6 and 9 months)
- The angioedema activity(at 3, 6 and 9 months)
研究者
研究点 (1)
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