Clinical trial NCT04832022: Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
Official title: Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Diseases
SARS-CoV Infection
COVID-19
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1500 CIR patients with or without SARS-COV2 vaccine.

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 populations.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of documented COVID-19 infection in vaccinated chronic inflammatory Rheumatism patients
timeFrame: At 3 months of the 1st dose of vaccine SARS-COV-2
measure: Proportion of documented COVID-19 infection in non vaccinated chronic inflammatory Rheumatism patients
timeFrame: At 3 months of the 1st dose of vaccine SARS-COV-2
Secondary outcomes:
measure: Proportion of documented COVID-19 infection
timeFrame: 6 months from 1st vaccine dose
measure: Proportion of documented COVID-19 infection
timeFrame: 12 months from 1st vaccine dose
measure: occurrence of infections by type of treatment
timeFrame: 6 months from 1st vaccine dose
measure: occurrence of infections by type of treatment
timeFrame: 12 months from 1st vaccine dose
measure: occurrence of infections by type of vaccine
timeFrame: 3 months from 1st vaccine dose
measure: Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 3 months
timeFrame: 3 months from 1st vaccine dose
measure: Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 6 months
timeFrame: 6 months from 1st vaccine dose
measure: Proportion of patients who developed local or systemic reactions to the vaccine, in the vaccinated group at 12 months
timeFrame: 12 months from 1st vaccine dose
measure: Proportion of patients who developed adverse events at 12 months
timeFrame: 12 months from 1st vaccine dose
measure: Proportion of patients with vaccine response
timeFrame: 3 months from 1st vaccine dose
measure: Proportion of patients with vaccine response
timeFrame: 6 months from 1st vaccine dose
measure: Proportion of responding patients
timeFrame: 3 months from 1st vaccine dose
measure: Proportion of responding patients
timeFrame: 6 months from 1st vaccine dose
measure: Proportion of responding patients
timeFrame: 12 months from 1st vaccine dose
measure: compare the evolution of disease activity
timeFrame: 3 months from first vaccine dose
measure: compare the evolution of disease activity
timeFrame: 6 months from first vaccine dose
measure: compare the evolution of disease activity
timeFrame: 12 months from first vaccine dose
measure: compare the evolution of disease activity
timeFrame: 3 months from first vaccine dose
measure: compare the evolution of disease activity
timeFrame: 6 months from first vaccine dose
measure: compare the evolution of disease activity
timeFrame: 12 months from first vaccine dose
measure: Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
timeFrame: 3 months from first vaccine dose
measure: Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
timeFrame: 6 months from first vaccine dose
measure: Psychological impact scores: anxiety (GAD7 : General Anxiety Disorder-7)
timeFrame: 12 months from first vaccine dose
measure: Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
timeFrame: 3 months from first vaccine dose
measure: Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
timeFrame: 6 months from first vaccine dose
measure: Psychological impact scores: depression (HADS : Hospital Anxiety and Depression Scale)
timeFrame: 12 months from first vaccine dose
measure: Psychological impact scores: quality of life (EQ5D)
timeFrame: 3 months from first vaccine dose
measure: Psychological impact scores: quality of life (EQ5D)
timeFrame: 6 months from first vaccine dose
measure: Psychological impact scores: quality of life (EQ5D)
timeFrame: 12 months from first vaccine dose
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre hospitalier universitaire de Montpellier
state: Occitanie
city: Brest
country: France
facility: CHU Brest
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Marseille
country: France
facility: CHU Marseille
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: APHP Saint Antoine
city: Paris
country: France
facility: APHP La pitié Salpêtrière
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
References: