Chronic Inflammatory Rheumatism
Conditions
Keywords
COVID-19, SARS-CoV2, Rheumatoid arthritis, Spondyloarthritis, Seroprevalence, Seropersistence
Brief summary
Accurate knowledge of the humoral immune responses induced by SARS-CoV-2 in patients undergoing immunosuppressive therapy is essential to guide recommendations for infected patients and for vaccination policy for uninfected immunosuppressed patients.
Detailed description
Longitudinal, cas-control study, observational multicenter study based on a cohort of 200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort. The follow-up the persistence of SARS-CoV-2 serological status for 2 years in 200 patients with inflammatory rheumatisms compared to matched 100 healthy controls to evaluate the impact of immuno-suppressive therapy will be proposed. Schedule: 4 visits over a 24-month period. An observational routine care study was initiated in 16 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs (Covid-RIC-1). The project plans to screen 5000 CIRs patients. The COVID-RIC-2 study will thus be proposed to these pre-screened subjects according to their positive status in the serology for SARS-CoV-2 at the time of their inclusion in COVID-RIC-1. For the control group, 100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients.
Interventions
BIOLOGICALBiological samples
Serum and plasma samples. At baseline, 6, 12 and 24 months
Sponsors
University Hospital, Montpellier
French Society of Rheumatology
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with rheumatoid arthritis or spondyloarthritis * With positive serology for SARS-CoV-2 infection less than 3 months old at the time of inclusion * Under biotherapy, or conventional synthetic Disease-modifying antirheumatic drugs (csDMARD) or Nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids for at least one month during the year 2020 * Agreeement to participate two years in the study
Exclusion criteria
* Pregnant or breastfeeding woman * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms | at baseline | Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls. | at 12 months after inclusion | To assess the maintenance of SARS-CoV-2 seroconversion at 12 months in patients with CIRs compared to non-CIR controls. |
| To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls | at 24 months after inclusion | To assess the maintenance of SARS-CoV-2 seroconversion at 24 months in patients with CIRs compared to non-CIR controls. |
| Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms | baseline | Assess the impact at baseline of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires |
Countries
France
Outcome results
None listed