Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000345

EU PAS number

EUPAS1000000345

Study ID

1000000345

Official title and acronym

A Drug Utilization Study to Evaluate the Effectiveness of Risk Minimization Measures (RMMs) for Abrocitinib in the EU Using Electronic Healthcare Data (B7451085)

DARWIN EU® study

No

Study countries

Denmark
France
Hungary
Spain
Sweden

Study description

The study objectives are to evaluate, to the extent measurable in the available routinely collected data, indicators of healthcare professional's adherence to the risk minimization measures in accordance with the abrocitinib Summary of Product Characteristics and prescriber's brochure.

Study status

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
InstitutionNon-Pharmaceutical companyENCePP partner
Pfizer
First published:
01/02/2024
Institution

Networks

The SIGMA Consortium (SIGMA)
Denmark
European Union
France
Germany
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
First published:
16/12/2024
Network
ENCePP partner

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Initial protocol

B7451085_ABROCITINIB PROTOCOL AMENDMENT 1_23MAY2024.pdf

English (590.14 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)