Study identification

EU PAS number

EUPAS107124

Study ID

107125

Official title and acronym

Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe

DARWIN EU® study

No

Study countries

Denmark
Spain
Sweden

Study description

This study aims to evaluate the long-term safety of upadacitinib use in adults in routine clinical care for the treatment of Ulcerative Colitis (UC) and Crohn's Disease (CD) Main objectives are to describe and compare the incidence of gastrointestinal (GI) perforation, and where possible, the incidence of fractures and drug-induced liver injury (DILI), in adults with UC or CD treated with upadacitinib, relative to those treated with select biologic inflammatory bowel disease (IBD) treatments at a similar line of therapy. To describe and compare, where possible, the incidence of the secondary safety outcomes, malignancy excluding non-melanoma skin cancer (NMSC), stratified by type, NMSC, major adverse cardiovascular events, venous thromboembolic event, serious infections (defined as all infections that require hospitalization, including opportunistic infections), herpes zoster, active tuberculosis, all-cause mortality, in adults with UC or CD treated with upadacitinib, relative to those treated with select biologic IBD treatments at a similar line of therapy.

Study status

Ongoing
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner

Contact details

Johan Reutfors

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
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)