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NCT04702295 | Not yet recruiting | Connective Tissue Diseases


ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)
Sponsor:

University of Pisa

Information provided by (Responsible Party):

Marta Mosca

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 period from January 2021 and January 2022. 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)

Condition or disease

Connective Tissue Diseases

Rare Diseases

Rheumatologic Disorder

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 of the vaccine in this population. The study will be promoted both in ERN ReCONNET Full Members and Affiliated Partners as well as in other centres treating and managing rare and complex connective tissue diseases. Study Objectives To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients; To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events; To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19; To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination

Study Type : Observational
Estimated Enrollment : 250 participants
Official Title: COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study
Actual Study Start Date : February 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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 Criteria
    • Pregnancy
    • All the exclusion criteria that apply for COVID-19 vaccination in the general population

ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)

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ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)

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