New or Flare of Musculoskeletal Rheumatic Diseases After Different COVID-19 Vaccines: Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- prevalence of flare of ARD after covid-19 vaccinations
研究概览
简要总结
Many patients develop autoimmune diseases after covid-19 vaccination, whether related to the vaccination or not, is still under study. This study will describe potential flare of ARD after COVID-19 vaccination, whether it leads to activity or new MSK manifestations development.
详细描述
-In this study: patients with known diagnosed rheumatic diseases who are vaccinated (one or full doses) of any type of COVID-19 vaccines will be enrolled. new ARD and prevalence of different MSK manifestations after covid-19 vaccinations also will be reported. The prevalence of flare of ARD after covid-19 vaccinations will be dteremined. Also we will compare between different types and doses of covid-19 vaccinations in inducing ARD or flares.
Study Design: Cross sectional study Target population: any patient with pre-existing received any vaccination against covid-19 visiting rheumatology outpatient clinic.
-any patient develops MSK manifestations after covid-19 vaccination. The disease activity sataus will be measured according to the type of rheumatic disease. For RA , disease activity score28 will be used, in lupus: SLEDAI, in Behcet : BDCAF, in SpA: BASDAI.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years Vaccinated against covid-19 (one dose or fully vaccinated)
排除标准
- •Receiving other vaccine e.g influenza Less than 18 years old
结局指标
主要结局
prevalence of flare of ARD after covid-19 vaccinations
时间窗: 3 months
flare of any manifestations of the disease
-Prevalence of new ARD after covid-19 vaccinations
时间窗: 3 moths
any ARD
次要结局
- Prevalence of non-specific MSK symptoms after Covid-19 vaccine.(3 months)
- Correlation of the MSK to the 1st and 2nd Covid vaccine dose(3 months)
- disease activity status in the patients who developed the ARD symptoms before and after the vaccine.(3 months)
- Any correlation between the appearance of MSK symptoms and the patient's medications(3 months)
- comparison between different type of covid-19 vaccine in inducing ARD or flare up.(3 months)
研究者
Mervat Eissa
Associate Professor
Cairo University