NL-OMON51059尚未招募不适用
Efficacy of B cell-targeted therapy in autoimmune bullous diseases - B cell-targeted therapy in AIBD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age of 18 years or older.
- •Diagnosis of pemphigus, based on the following criteria: clinical features
- •suggestive of pemphigus vulgaris or pemphigus foliaceus; a histological image
- •of intraepidermal acantholysis; and/or deposition of IgG, complement component
- •3, or both on the keratinocyte membrane detected by direct immunofluorescence
- •Diagnosis of pemphigoid, based on the following criteria: linear depositions
- •of IgG, IgA, IgM, or C3c along the BMZ by direct immunofluorescence microscopy
- •(DIF) and/or positive indirect immunofluorescence microscopy (IIF) on
- •salt-split skin (SSS), in combination with clinical presentation,
- •histopathological findings, or other immunoserological tests compatible with
- •the diagnosis of a pemphigoid disease.
- •Administration of rituximab according to the following protocol: two infusion
- •of 1000mg within an interval of two weeks, followed by 500mg at month 6 and
- •month 12, or in patients with severe pemphigus 1000mg at month 6, or in
- •patients who are not in complete remission two infusions of 1000mg two weeks
排除标准
- •Patients under the age of 18 years.
- •Plasma exchange, plasmapheresis or immunoadsorption within the last 3 months
研究者
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