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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}, {'id': 'D003095', 'term': 'Collagen Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (any type)', 'timeFrame': '12 months'}, {'measure': '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', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of disease flare post-vaccination', 'timeFrame': '12 months'}, {'measure': 'Incidence of serious adverse events', 'timeFrame': '12 months'}, {'measure': 'Incidence of life-threatening adverse events and deaths', 'timeFrame': '12 months'}, {'measure': 'Incidence of adverse events of special interest for COVID-19', 'timeFrame': '12 months'}, {'measure': 'Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up', 'timeFrame': '12 months'}, {'measure': 'Comparison of the incidence of COVID-19 among different types of vaccines', 'timeFrame': '12 months'}, {'measure': 'Significant anti COVID 19 antibodies titer at 3 and 6 months', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Connective Tissue Diseases', 'Rare Diseases', 'Rheumatologic Disorder']}, 'descriptionModule': {'briefSummary': "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.\n\nPatients with the following diagnosis will be included:\n\n* antiphospholipid syndrome (APS),\n* Ehlers-Danlos syndrome (EDS),\n* idiopathic inflammatory myopathies (IIM),\n* IgG4-related disease (IgG4),\n* mixed connective tissue disease (MCTD),\n* relapsing polychondritis (RP),\n* Sjogren's syndrome (SS),\n* systemic lupus erythematosus (SLE),\n* systemic sclerosis (SSc)\n* undifferentiated connective tissue disease (UCTD)", 'detailedDescription': "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.\n\nStudy Objectives\n\n1. To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients;\n2. To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events;\n3. To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;\n4. To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients\n5. To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult (\\>18 years) patients with a diagnosis of rCTDs who will be given the vaccine during the period from January 2021 and January 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with the following diagnosis will be included:\n\n* antiphospholipid syndrome (APS),\n* Ehlers-Danlos syndrome (EDS),\n* idiopathic inflammatory myopathies (IIM),\n* IgG4-related disease (IgG4),\n* mixed connective tissue disease (MCTD),\n* relapsing polychondritis (RP),\n* Sjogren's syndrome (SS),\n* systemic lupus erythematosus (SLE),\n* systemic sclerosis (SSc)\n* undifferentiated connective tissue disease (UCTD)\n\nExclusion Criteria:\n\n* Pregnancy\n* All the exclusion criteria that apply for COVID-19 vaccination in the general population"}, 'identificationModule': {'nctId': 'NCT04702295', 'acronym': 'VACCINATE', 'briefTitle': 'ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'UPISA2'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor in Rheumatology', 'investigatorFullName': 'Marta Mosca', 'investigatorAffiliation': 'University of Pisa'}}}}