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临床试验/TCTR20210917003
TCTR20210917003进行中(未招募)不适用

Immunogenicity and safety of COVID-19 vaccines in SLE and rheumatoid arthritis patients

Ratchadapiseksompotch Fund, Faculty of Medicine0 个研究点目标入组 100 人开始时间: 2021年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100

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 Years 至 65 Years(—)
性别
All

入选标准

  • Age 18-65 years old
  • Diagnosis of SLE according to American College of Rheumatology (ACR) 1997 or The Systemic Lupus International Collaborating Clinics (SLICC) criteria or or EULAR/ACR classification
  • Diagnosis of RA according to 2010 ACR and European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis

排除标准

  • History of SARS-CoV-2 infection
  • Receipt of covid-19 vaccine prior to study enrollment
  • Severe extra-renal involvement of SLE
  • Receipt of prednisolone > 20 mg/day
  • Receipt of mycophenolate mofetil(MMF) > 1.5 g/day
  • Receipt of azathioprine > 2 mg/kg/day
  • Treatment with cyclophosphamide within 1 month
  • Treatment with biologic agents within the past 6 months
  • Severe SLE flare including: CNS involvement, Vasculitis, Nephritis, Platelet < 60,000, Hemolytic anemia: Hgb < 7 g/dL or decrease in Hgb > 3 g/dL
  • Not receiving immunosuppressive treatment

研究者

发起方
Ratchadapiseksompotch Fund, Faculty of Medicine

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