Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000429

EU PAS number

EUPAS1000000429

Study ID

1000000429

Official title and acronym

DARWIN EU® - Characterisation of exposure to acitretin and purpura and related conditions

DARWIN EU® study

Yes

Study countries

Denmark
Netherlands
Spain
United Kingdom

Study description

The Marketing Authorisation Holders (MAHs) that hold Marketing Authorisations (MAs) for acitretin in Canada and the US have included purpura in their label. The Pharmacovigilance Risk Assessment Committee (PRAC) requested additional real-world evidence (RWE) to assess the causal association between certain purpura and related conditions and acitretin before deciding whether to include selected purpura and related conditions in section 4.4 (or 4.8) of the Summary of product characteristics (SmPC) of acitretin.
Acitretin (D05BB02) is a synthetic aromatic analogue of retinoic acid. Retinol (a derivative of Vitamin A) is known to be essential for normal epithelial growth and differentiation. Acitretin is a Nationally Authorised Product (NAP) with approved indications including severe forms of psoriasis (erythrodermic psoriasis and local or generalized pustular psoriasis); severe disorders of keratinization such as congenital ichthyosis, pityriasis rubra pilaris, and Darier’s disease. And other disorders of keratinization which may be resistant to other therapies. It is authorised in the majority of EU countries (not in Bulgaria, Cyprus, Greece, Malta, Romania).
This study aims to characterise patients treated with acitretin, estimate the incidence rate of purpura and related conditions in patients with treatment indications for acitretin.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Cheryl Tan

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-021_Acitretin and purpura_V2.pdf

English (921.97 KB - 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