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| ID | Type | Description | Link |
|---|---|---|---|
| UF8074 | Other Identifier | Montpellier University Hospital |
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| Name | Class |
|---|---|
| French Society of Rheumatology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) | 200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological samples | Biological | Serum and plasma samples. At baseline, 6, 12 and 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms | Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms | at baseline |
| Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms | Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at 6 months in patients with chronic inflammatory rheumatisms | at 6 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls. | To assess the maintenance of SARS-CoV-2 seroconversion at 12 months in patients with CIRs compared to non-CIR controls. | at 12 months after inclusion |
| To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls |
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Inclusion Criteria:
Exclusion Criteria:
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200 participants with chronic inflammatory rheumatisms and positive status in the serology for SARS-CoV-2. This population will be compared with a healthy control group from the cohort Covid-Biotoul
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hopsitalier universitaire de Montpellier | Montpellier | Occitanie | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39436731 | Result | Ruyssen-Witrand A, Dimeglio C, Nogue E, Molinary N, Pham T, Gaujoux-Viala C, Miceli-Richard C, Fogel O, Herin F, Martin-Blondel G, Berenbaum F, Breuil V, Chary-Valckenaere I, Confavreux C, Devauchelle-Pensec V, Fautrel B, Flipo RM, Mulleman D, Richez C, Tournadre A, Vittecoq O, Constantin A, Izopet J, Morel J. Comparison of SARS-COV-2 humoral response between rheumatoid arthritis, psoriatic arthritis and spondyloarthritis patients and controls in two unvaccinated cohorts. Clin Exp Rheumatol. 2024 Nov;42(11):2141-2149. doi: 10.55563/clinexprheumatol/48440j. Epub 2024 Oct 17. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Serum and plasma samples at baseline. Serum samples at 0, 6, 12 and 24 months.
To assess the maintenance of SARS-CoV-2 seroconversion at 24 months in patients with CIRs compared to non-CIR controls. |
| at 24 months after inclusion |
| Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms | 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 | baseline |
| Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms | Assess the impact at 6 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires | at 6 month after inclusion |
| Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms | Assess the impact at 12 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires | at 12 month after inclusion |
| Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms | Assess the impact at 24 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires | at 24 month after inclusion |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |