Study identification

PURI

https://redirect.ema.europa.eu/resource/106437

EU PAS number

EUPAS106436

Study ID

106437

Official title and acronym

DARWIN EU® Treatment patterns of drugs used in adult and paediatric population with systemic lupus erythematosus

DARWIN EU® study

Yes

Study countries

France
Germany
Spain
United Kingdom

Study description

Systemic SLE erythematosus: SLE is a multisystem autoimmune disorder of connective tissue characterized by autoantibodies that target nuclear antigens, remissions and flares, and a highly variable clinical presentation, disease course, and prognosis. The disease course is more severe in childhood-onset compared to adult-onset SLE, with higher prevalence of morbidity and lower survival rates. In contrast to adult SLE, there is limited good quality evidence on the treatment of childhood SLE. Therefore, to review new drug applications, it would be important for the European Medicines Agency EMA to understand the current clinical practice of treating SLE in paediatric population and differences with the treatment in adult population. The overall objective of this study is to characterise paediatric and adult patients with SLE diagnosed in the period 2013-2022. This will be a patient-level characterisation and drug utilisation study.

Study status

Finalised
Research institution and networks

Institutions

Networks

Contact details

Daniel Prieto Alhambra

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

Study Protocol P2 C1-006 Version 2.1 final

English (1.93 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