Study identification

EU PAS number

EUPAS1000000206

Study ID

1000000206

Official title and acronym

Non-interventional post-authorization prospective cohort study evaluating the effectiveness of the additional risk minimization measures for filgotinib (Jyseleca®) use in patients with ulcerative colitis: a European multi registry-based study

DARWIN EU® study

No

Study countries

Netherlands
Spain
Sweden

Study description

This longitudinal drug utilization study (DUS) aims to evaluate the effectiveness of the additional risk minimization measures (aRMMs) by assessing how healthcare professionals (HCPs) prescribe filgotinib for the treatment of patients with ulcerative colitis. This non-interventional, post-authorization, prospective, multi-country registry-based cohort study is being conducted based on real-word clinical data derived from 3 European inflammatory bowel disease (IBD) registries, namely the Nationwide Study on Genetic and Environmental Determinants of Inflammatory Bowel Disease (ENEIDA) Register from Spain (ES), the Initiative on Crohn’s and Colitis (ICC) Register from the Netherlands (NL), and the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG).

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
Alfasigma
Italy
First published:
30/08/2024
Institution Pharmaceutical company

Networks

ENEIDA (ES), ICC (NL), SWIBREG (SE)

Contact details

Rachel Weinrib

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

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

Alfasigma S.p.A
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)