NCT05313061Unknown3 期
Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Covid-19 antibody titer before and after Covid-19 vacciation
研究概览
简要总结
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 19 years of age at time of consent
- •Have a diagnosis of RA per ACR criteria
- •Require methotrexate for RA treatment
- •Subject to a Covid-19 booster vaccination
- •Must understand and voluntarily sign an informed consent form including writing consent for data protection
排除标准
- •Pregnant or lactating females
- •Previous anaphylactic response to the vaccine components
- •Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
- •Any condition including laboratory abnormality which places the subject at unacceptable risk
- •Subjects who decline to participate
研究组 & 干预措施
MTX continue
Active Comparator
Group will continue MTX after vaccination
干预措施: MTX (Drug)
MTX 1 week hold
Experimental
Group will continue MTX for 1 week after vaccination
干预措施: MTX (Drug)
结局指标
主要结局
Covid-19 antibody titer before and after Covid-19 vacciation
时间窗: 2 weeks
Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination
次要结局
- T cell activation after vaccination(2, 4, 16 weeks)
- B cell activation after vaccination(2, 4, 16 weeks)
研究者
Eun Bong Lee
Professor
Seoul National University Hospital
研究点 (1)
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进行中（未招募）
不适用
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进行中（未招募）
不适用
To understand the immunogenicity of Covisheild vaccine in patients with rheumatological disease by discontinuing methotrexate temporarily after taking second dose of vaccineCTRI/2021/07/035307Centre for Arthritis and Rheumatism Excellence CARE