Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

397 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-07

Study Completion Date

2023-06-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatic Diseases SARS-CoV Infection COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccinated

Seronegative Chronic Inflammatory Rheumatism (CIR) who accepted vaccination against SARS-CoV2

Biological samples

Intervention Type OTHER

Serum and plasma samples. At baseline, 3, 6 and 12 months

Non vaccinated

Seronegative Chronic Inflammatory Rheumatism (CIR) who refused vaccination against SARS-CoV2

Biological samples

Intervention Type OTHER

Serum and plasma samples. At baseline, 3, 6 and 12 months

Interventions

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Biological samples

Serum and plasma samples. At baseline, 3, 6 and 12 months

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No