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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04702295
Other study ID # UPISA2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2021
Est. completion date August 2023

Study information

Verified date January 2021
Source University of Pisa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date August 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Pisa

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (any type) 12 months
Primary COVID-19 incidence in patients with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen - cases confirmed =7 days after the last dose 12 months
Secondary Incidence of disease flare post-vaccination 12 months
Secondary Incidence of serious adverse events 12 months
Secondary Incidence of life-threatening adverse events and deaths 12 months
Secondary Incidence of adverse events of special interest for COVID-19 12 months
Secondary Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up 12 months
Secondary Comparison of the incidence of COVID-19 among different types of vaccines 12 months
Secondary Significant anti COVID 19 antibodies titer at 3 and 6 months 3 and 6 months
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