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临床试验/EUCTR2021-001414-10-NL
EUCTR2021-001414-10-NL进行中(未招募)1 期

Vaccine response against SARS-CoV-2 in patients with primary Sjögren’s syndrome - VaccineSS

niversity Medical Center Groningen0 个研究点目标入组 180 人开始时间: 2021年3月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
180

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age 18-75 years
  • Written informed consent
  • Fulfilment of 2016 ACR-EULAR criteria (for pSS patients)
  • Female sex (for healthy volunteers)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 135
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 45

排除标准

  • Confirmed SARS-CoV-2 infection (current or previous)
  • Women who are pregnant (self-reported, participants will be asked -when in doubt- to perform a pregnancy test before study entry)
  • Current use of prednisone >10mg/day, conventional DMARDs (except hydroxychloroquine) or biological DMARDS. Previous use of DMARDs =6 months before inclusion (=12 months for rituximab) is allowed.

研究者

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