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

University of Pisa

Status: Unknown

Conditions: Rheumatologic Disorder; Connective Tissue Diseases; Rare Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT04702295

UPISA2

Details and patient eligibility

About

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)

Full 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

1. To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients;
2. To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events;
3. To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;
4. To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients
5. To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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