Study identification

EU PAS number

EUPAS1000000512

Study ID

1000000512

Official title and acronym

An Active Surveillance Study to Monitor the Real-World Safety of Ritlecitinib Among Patients with Alopecia Areata in Denmark, France, and Sweden

DARWIN EU® study

No

Study countries

Denmark
France
Sweden

Study description

This is a non-interventional study (NIS) based on routinely collected electronic healthcare data from routine clinical practice aiming to actively monitor the safety events of interest following exposure to ritlecitinib, baricitinib or other approved systemic treatments for Alopecia Areata (AA) following the EU approval of ritlecitinib.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Dominique Sighoko

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
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)