NCT05366127尚未招募不适用
Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
University Hospital, Rouen11 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Evolution of IGA Score between baseline and 6-month follow-up visit
研究概览
简要总结
The aim of the study is to validate a global and simple score : IGA (Investigator Global Assessment) score for the evaluation of the extent and severity of the disease in patients with bullous pemphigoid
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
- •Consecutive adult patients aged ≥ 18 years
- •Newly diagnosed or relapsing BP
- •Clinical features suggestive of classic BP AND suggestive histological features AND deposition of IgG and/ or C3 deposits on the dermal epiderma junction, AND detection of circulating anti-epidermal antibodies labelling the epidermal side of salt-split skin
- •Patient having read and understood the information letter and not opposed to participation
- •Must be willing and able to adhere to all specified requirements, including but not limited to adherence to the follow-up visits
排除标准
- •Predominant or exclusive mucosal involvement leading to suspect the diagnosis of mucous membrane pemphigoid
- •Pemphigoid gestationis
- •Linear IgA dermatosis (predominant or exclusive IgA deposits on the DEJ)
- •Skin lesions suggesting the diagnosis of epidermolysis bullosa acquisita (skin fragility, atrophy, milia)
结局指标
主要结局
Evolution of IGA Score between baseline and 6-month follow-up visit
时间窗: 6 months
IGA score : 0 to 4
BPDAI Score between baseline and 6-month follow-up visit
时间窗: 6 months
BPDAI : 0 to 120
次要结局
- Evolution of IGA Score between baseline and 3-weeks follow-up visit(3 weeks)
- Evolution of IGA Score between baseline and 3-month follow-up visit(3 months)
- Evolution of IGA Score between baseline and 2-month follow-up visit(2 months)
- Evolution of IGA Score between baseline and 1-month follow-up visit(1 month)
- Evolution of IGA Score between baseline and 2-weeks follow-up visit(2 weeks)
- Evolution of IGA Score between baseline and 1-week follow-up visit(1 week)
- Evolution of BPDAI Score between baseline and 3-month follow-up visit(3 months)
- Evolution of BPDAI Score between baseline and 2-month follow-up visit(2 months)
- Evolution of BPDAI Score between baseline and 1-month follow-up visit(1 month)
- Evolution of BPDAI Score between baseline and 3 weeks follow-up visit(3 weeks)
- Evolution of BPDAI Score between baseline and 2 weeks follow-up visit(2 weeks)
- Evolution of BPDAI Score between baseline and 1 week follow-up visit(1 week)
研究者
研究点 (11)
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