Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-01-09 @ 6:56 PM
Study NCT ID:
NCT04702295
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)
Sponsor:
University of Pisa
Organization:
Study Overview
Official Title:
COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VACCINATE
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)
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)
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
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: