Status: Ongoing First registered on: 06/09/2023
Last updated on: 13/11/2023
1. Study identification
EU PAS Register NumberEUPAS106436
Official titleDARWIN EU® CC Treatment patterns of drugs used in adult and paediatric population with systemic lupus erythematosus
Study title acronym
Study typeObservational study
Brief description of the studySystemic 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU® CC
Centre locationRotterdam the Netherlands
Details of (Primary) lead investigator
Title Professor
Last name Prieto Alhambra
First name Daniel
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5
IQVIA DA Germany, Germany
IDIAPJGol SIDIAP, Spain
PSMAR IMASIS, Spain
University of Bordeaux CDW Bordeaux, France
University of Oxford CPRD GOLD, United Kingdom
Countries in which this study is being conducted
International study

France
Germany
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/07/202306/07/2023
Start date of data collection01/01/201301/01/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Prieto Alhambra
First name Daniel
Address line 1Dr Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org
Public Enquiries
Title Mrs 
Last name Schuemie 
First name Ilse 
Address line 1Dr Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org 
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