Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 13
- 主要终点
- Proportion of documented COVID-19 infection in vaccinated chronic inflammatory Rheumatism patients
研究概览
简要总结
To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.
详细描述
Longitudinal, comparative, controlled, observational multicenter study based on a cohort of 1500 SARS-CoV-2 seronegative patients with CIRs from the COVID-RIC1 cohort: 750 accepting vaccination and 750 refusing vaccination matched on age (+/-10 years), gender, rheumatism and recruiting center. Schedule: 4 visits over a 12-month period.
An observational routine care study was initiated in 15 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs. The project plans to screen 5000 CIRs patients. The COVID-RIC3 study will thus be proposed to these pre-screened subjects according to their agreement or refusal to be vaccinated against COVID-19 based on a question asked at the time of their inclusion in COVID-RIC1.
The efficacy and safety of the SARS-CoV2 vaccines as well as the vaccine-induced humoral immune responses and their maintenance over time in immunosuppressed patients with CIRs are essential to guide vaccine recommendations in these specific immunocompromised populations in terms of "boost" or booster.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adult ≥ 18 years old,
- •Chronic inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis, axial SpA, diagnosed by a rheumatologist
- •Having a negative serology for SARS-CoV-2 infection upon inclusion in COVID-RIC
- •Under csDMARD (conventional synthetic Disease-modifying antirheumatic drug), biotherapy, JAK inhibitor or under symptomatic treatment such as NSAIDs or corticosteroids alone or in combination with a DMARD (Disease-modifying antirheumatic drug)
- •Subject having signed a consent
- •Affiliated with Social Security
- •Having accepted or agreed to be vaccinated against COVID-19 (for vaccine group)
- •Having refused to be vaccinated against COVID-19 (for non-vaccine group)
排除标准
- •Adult patient under legal protection (guardian, curator)
- •Patient vaccinated with an anti-SARS-CoV-2 vaccine before the serological test
- •Refusal to be vaccinated (for vaccine group)
- •Acceptance to be vaccinated (for non-vaccine group))
- •Refusal to participate in the study
- •Pregnancy and breast feeding
结局指标
主要结局
Proportion of documented COVID-19 infection in vaccinated chronic inflammatory Rheumatism patients
时间窗: At 3 months of the 1st dose of vaccine SARS-COV-2
Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in vaccinated chronic inflammatory Rheumatism patients
Proportion of documented COVID-19 infection in non vaccinated chronic inflammatory Rheumatism patients
时间窗: At 3 months of the 1st dose of vaccine SARS-COV-2
Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in non vaccinated chronic inflammatory Rheumatism patients
次要结局
- occurrence of infections by type of treatment(12 months from 1st vaccine dose)
- Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 3 months(3 months from 1st vaccine dose)
- Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 12 months(12 months from 1st vaccine dose)
- Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)(12 months from first vaccine dose)
- Psychological impact scores: quality of life (EQ5D)(12 months from first vaccine dose)
- Proportion of documented COVID-19 infection(12 months from 1st vaccine dose)
- Proportion of patients who developed adverse events at 12 months(12 months from 1st vaccine dose)
- compare the evolution of disease activity(12 months from first vaccine dose)
- occurrence of infections by type of vaccine(3 months from 1st vaccine dose)
- Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 6 months(6 months from 1st vaccine dose)
- Proportion of patients with vaccine response(6 months from 1st vaccine dose)
- Proportion of responding patients(12 months from 1st vaccine dose)
- Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)(12 months from first vaccine dose)