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临床试验/CTRI/2025/06/089549
CTRI/2025/06/089549尚未招募不适用

Efficacy and safety of Rituximab infusion in pemphigus patients: A retrospective study

Dr Harshini S1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年7月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Pemphigus Area and Activity Score (PAAS)

研究概览

简要总结

This is a retrospective study to assess the efficacy and safety of Rituximab infusion in pemphigus patients in our institute based on the records available in the department register. Rituximab was FDA approved in 2018 for the treatment of moderate to severe pemphigus vulgaris and it has been increasingly used and has revolutionized the treatment of immunobullous diseases resulting in the major shift of focus from more global immunosuppression to targeted immunotherapy. This study purpose is to provide critical analysis of use of rituximab in the treatment of pemphigus patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.All pemphigus patients (fresh, relapse, and recalcitrant cases) with diagnosis confirmed by typical clinical presentation, direct immunofluorescence and biopsy who had received rituximab infusion 2.Patients with proper clinical records available.
  • 3.Uninterrupted clinical follow-up of at least 12 months since the first rituximab treatment.

排除标准

  • Patients with missed data and lost to follow up.

结局指标

主要结局

Pemphigus Area and Activity Score (PAAS)

时间窗: Baseline, 4 weeks and 8 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Harshini S
申办方类型
Other [self]

研究点 (1)

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