Study identification

PURI

https://redirect.ema.europa.eu/resource/199004

EU PAS number

EUPAS107885

Study ID

199004

Official title and acronym

Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe

DARWIN EU® study

No

Study countries

Denmark
Spain
Sweden

Study description

The study aims to evaluate the use of upadacitinib in patients with ulcerative colitis (UC) in routine clinical care in Denmark, Sweden, and Spain.

The study objectives are:
1. To describe the baseline characteristics of patients with UC who are new users of upadacitinib.
2. To the extent measurable, evaluate healthcare utilization in routine clinical care as indicator of physician adherence to the additional risk minimisation measures (aRMMs) among patients with UC who are new users of upadacitinib, by:
a) Quantifying the compliance to recommendations for posology (average daily dose) and duration of use;
b) Quantifying the compliance to recommendations for the use among patients who have risk factors for gastrointestinal (GI) perforation, malignancy, major adverse cardiovascular events (MACE), venous thromboembolic events (VTE), and serious infections;
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 tuberculosis (TB);
e) Quantifying the compliance to recommendations for patient screening and laboratory monitoring prior to and during upadacitinib treatment (Denmark 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 (Sweden only), 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 higher maintenance dose of upadacitinib 30 mg.

Study status

Ongoing
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Johan Reutfors

Primary lead investigator
Study timelines

Date when funding contract was signed

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

p24344-protocol-pmos-v1.2_10Nov2023_Redacted 2_21Jun2024.pdf

English (12.27 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)