Study identification

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 institutions and networks

Institutions

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
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable