Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000233

EU PAS number

EUPAS1000000233

Study ID

1000000233

Official title and acronym

SAFETY-VAC: Background incidence estimation of flares of pre-existing chronic diseases using pan-European electronic healthcare data sources. (SAFETY VAC)

DARWIN EU® study

No

Study countries

Denmark
Finland
France
Italy
Norway
Spain
United Kingdom

Study description

This study aims to assess the feasibility of the participating European data sources in estimating the background incidence, and the 6- and 12-month cumulative incidence of flares of selected autoimmune diseases (Graves’ disease, Hashimoto’s thyroiditis, polyarteritis nodosa, autoimmune hepatitis, rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, erythema nodosum, systemic lupus erythematosus, and ulcerative colitis) using electronic healthcare record data sources from 7 European countries. The estimates will be stratified by age categories (< 18, 18-59, >60 years old), sex, and selected sub-populations. This study will also assess the contribution of different data provenances and components of the flares definitions to the flare incidence estimation. 

Study status

Ongoing
Research institution and networks

Institutions

Pedianet network
Italy
First published:
01/02/2024
InstitutionOther
Teamit Institute
Spain
First published:
12/03/2024
InstitutionOtherENCePP partner
Utretch University (UU), University of Eastern Finland (UEF)

Networks

Contact details

Carlos Durán Salinas

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

SAFETY-VAC_Study_Protocol.pdf

English (1.03 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable