Study identification

PURI

https://redirect.ema.europa.eu/resource/107455

EU PAS number

EUPAS107454

Study ID

107455

Official title and acronym

DARWIN EU® Natural history of dermatomyositis (DM) and polymyositis (PM) in adults and paediatric populations

DARWIN EU® study

Yes

Study countries

Estonia
France
Germany
Spain
United Kingdom

Study description

The overall objective of this study is to describe and characterise dermatomyositis (DM), polymyositis (PM) and their juvenile forms (JDM and JPM), in terms of prevalence, natural history of the disease, disease severity, and treatment. The specific objectives of this study are to estimate the yearly prevalence of DM and PM in adult and paediatric populations, overall and by sex, to characterise patients and describe age at disease onset for DM, PM, JDM and JPM, to describe the occurrence in adults and children of biomarker measurements and clinical manifestations and to describe disease severity including organ involvement before, at the time, and after a diagnosis of DM, PM, JDM and JPM. Additionally, the objective of the study is to describe treatment administered after a diagnosis of DM, PM, JDM and JPM.

Study status

Finalised
Research institution and networks

Institutions

University of Bordeaux
France
First published:
01/02/2024
Institution
Educational Institution
University of Oxford, United Kingdom

Networks

Contact details

Albert Prats Uribe

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU Final Study Protocol P2 C1-007 DM and PM

English (1.71 MB - PDF)View document
Updated protocol

Darwin_EU_Study_Protocol_P2-C1-007_v1.1final.pdf

English (1.67 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