Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination (COVID-RIC3)
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Details and patient eligibility
About
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.
Full 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 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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
Trial design
397 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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