Status:
UNKNOWN
ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)
Lead Sponsor:
University of Pisa
Conditions:
Connective Tissue Diseases
Rare Diseases
Eligibility:
All Genders
18-99 years
Brief Summary
30 months, multicentre, prospective observational study on adult (\>18 years) patients with a diagnosis of rare and complex connective tissue diseases (rCTDs) who will be given the vaccine during the ...
Detailed Description
This is an observational study aimed at gathering sufficient number of cases of rCTDs patients who will receive COVID-19 vaccination that will help in better understanding of both safety and efficacy ...
Eligibility Criteria
Inclusion
- Patients with the following diagnosis will be included:
- antiphospholipid syndrome (APS),
- Ehlers-Danlos syndrome (EDS),
- idiopathic inflammatory myopathies (IIM),
- IgG4-related disease (IgG4),
- mixed connective tissue disease (MCTD),
- relapsing polychondritis (RP),
- Sjogren's syndrome (SS),
- systemic lupus erythematosus (SLE),
- systemic sclerosis (SSc)
- undifferentiated connective tissue disease (UCTD)
Exclusion
- Pregnancy
- All the exclusion criteria that apply for COVID-19 vaccination in the general population
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04702295
Start Date
February 1 2021
End Date
August 1 2023
Last Update
January 8 2021
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