Status:
COMPLETED
Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Rheumatic Diseases
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Brief Summary
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 pop...
Detailed Description
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 75...
Eligibility Criteria
Inclusion
- 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-RIC1.
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT04832022
Start Date
April 7 2021
End Date
June 27 2023
Last Update
August 14 2023
Active Locations (13)
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1
Centre hospitalier universitaire de Montpellier
Montpellier, Occitanie, France, 34295
2
CHU Brest
Brest, France, 29200
3
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
4
CHU Marseille
Marseille, France, 13274