Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000166

EU PAS number

EUPAS49233

Study ID

1000000166

Official title and acronym

Drug Utilization Study Evaluating Additional Risk Minimization Measures for Upadacitinib in the Treatment of Atopic Dermatitis in Europe

DARWIN EU® study

No

Study countries

Denmark
Germany
Spain
Sweden

Study description

The study aims to evaluate the use of upadacitinib (RINVOQ®) in individuals with AD in routine clinical care in Denmark, Germany, Spain, and Sweden. The study objectives are:
1. To describe the baseline characteristics of individuals with AD who are new users of upadacitinib.
2. To the extent measurable, evaluate healthcare utilization in routine clinical care as an indicator of physician adherence to the aRMMs among individuals with AD who are new users of upadacitinib, by:
a. Quantifying the compliance to recommendations for posology (average daily dose) and by describing the duration of use.
b. Quantifying the compliance to recommendations for the use among individuals who have risk factors for GI perforation, serious infections, malignancy, MACE, and VTE.
c. Quantifying the compliance to the recommendations for the use among patients aged 65 years and older.
d. Quantifying the compliance to the recommendations for contraindicated use including pregnancy, and active TB.
e. Quantifying the compliance to recommendations for patient screening and laboratory monitoring prior to and during upadacitinib treatment (Denmark, Germany, and Spain only).
3. To describe the changes in the utilization of upadacitinib following the implementation of revised aRMMs from the Article 20 referral procedure, specifically:
a. Describe the use of upadacitinib among patients with risk factors for VTE, MACE, malignancy, and serious infections.
b. Describe the use of upadacitinib among patients aged 65 years and older.
c. Describe the use of upadacitinib 30 mg.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Johan Reutfors

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 final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
Study protocol
Initial protocol

p21825-protocol-pmos-v3.2_Redacted.pdf

English (2.04 MB - 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)