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临床试验/TCTR20221213001
TCTR20221213001已完成不适用

Optimal time for COVID-19 vaccination in rituximab-treated dermatologic patients

Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University0 个研究点目标入组 113 人开始时间: 2022年12月13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
113

研究概览

简要总结

The regression analysis demonstrated a negative association between rituximab exposure status and SR but not with SARS-CoV-2-specific IgG levels. Nine-month rituximab-to-vaccination cut-off fulfilled our prespecified diagnostic performance (SR difference between groups [95%CI]: -2.6 [-23.3, 18.1], LR+: 2.6) and coincided with the repopulation of naive B lymphocytes in these patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 N/A (No limit)(—)
性别
All

入选标准

  • 1. Being participants of our previous prospective cohort study or the one conducted parallel to ours by rheumatologists in the same institution, which evaluated immunogenicity of various types of COVID-19 vaccines in patients with immune-mediated dermatologic diseases (TCTR20220317008)
  • 2. Subjects who received at least one course of rituximab using any protocols before vaccination were included as an exposed group.
  • 3. Rituximab-naive subjects were recruited as an unexposed group.
  • *exposed and unexposed group were matched for age and sex.

排除标准

  • 1. Subjects received rituximab or were diagnosed with COVID-19 between the first dose vaccination to the vaccine's immunogenicity assessment date
  • 2. The vaccine's immunogenicity data were missing

研究者

发起方
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University

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