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The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.
This is an observational, longitudinal, multicenter study, including patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country. Patients will be followed for 12 months and two evaluations will be performed, one at baseline and the other after the follow-up time is completed.
The aim of this registry is to evaluate the efficacy and safety of the SARS-CoV-2 vaccines in patients with rheumatic diseases.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine | Biological | Patients with rheumatic diseases who have been vaccinated for COVID-19 |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Vaccine efficacy | Number of patients who develop SARS-CoV-2 infection after vaccination | 12 month |
| COVID-19 Vaccine safety | Number of patients who develop adverse events asssociated with vaccination | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| New immunomediated events | Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events. | 12 month |
| Flare | Number of patients who develop a flare asssociated with vaccination. Description |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Isnardi, MD | Contact | +5491169583394 | carolina.isnardi@reumatologia.org.ar | |
| Guillermo Pons-Estel, PhD, MD | Contact | +5493412644125 | unisar@reumatologia.org.ar |
| Name | Affiliation | Role |
|---|---|---|
| Carolina Isnardi, MD | Unidad de Investigación Sociedad Argentina ReumatologÃa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sociedad Argentina de ReumatologÃa | Recruiting | Buenos Aires | Buenos Aires F.D. | 1022 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35760939 | Derived | Isnardi CA, Schneeberger EE, Kreimer JL, Luna PC, Echeverria C, Roberts K, de la Vega MC, Virasoro BM, Landi M, Quintana R, Exeni MED, Kogan N, Petkovic I, Pereira D, De Los Angeles Correa M, Zelaya MD, Tissera Y, Elkin MSG, Pisoni CN, Alonso C, Cogo AK, Cosatti MA, Garcia L, Retamozo C, de Los Angeles Severina M, Nieto RE, Rosemffet M, Mussano E, Bertoli A, Savio VG, Cosentino V, Pons-Estel GJ. An Argentinean cohort of patients with rheumatic and immune-mediated diseases vaccinated for SARS-CoV-2: the SAR-CoVAC Registry-protocol and preliminary data. Clin Rheumatol. 2022 Oct;41(10):3199-3209. doi: 10.1007/s10067-022-06253-5. Epub 2022 Jun 28. |
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 12 months |
| Changes in the rheumatic disease treatment | Changes in the rheumatic disease treatment associated with vaccination, and study its influence on the efficacy (number of patients who develop SARS-CoV-2 infection after vaccination) and safety (number of patients who develop adverse events asssociated with vaccination) of the vaccine for SARS-CoV-2. | 12 months |
| Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases | Differences in the efficacy/safety profile of SARS-CoV-2 vaccine among patients with immune mediated and non-immune mediated rheumatic diseases. | 12 months |
| Sociedad Argentina de Reumatologia | Recruiting | Buenos Aires | 1022 | Argentina |
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