Study identification

PURI

https://redirect.ema.europa.eu/resource/108231

EU PAS number

EUPAS106566

Study ID

108231

Official title and acronym

Non-interventional, post-authorization prospective safety study of filgotinib in patients with moderately to severely active ulcerative colitis: a European multi registry-based study

DARWIN EU® study

No

Study countries

Netherlands
Spain
Sweden

Study description

This study aims to further evaluate the long-term safety (LTS) of filgotinib in the treatment of patients with moderately to severely active ulcerative colitis (UC) under real-world conditions, specifically with respect to important identified and potential risks listed in the Jyseleca® risk management plan (RMP). This non-interventional, post-authorization, prospective, multi-country registry-based safety cohort study is being conducted based on real-word data derived from 3 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
InstitutionNot-for-profitENCePP partner
Alfasigma
Italy
First published:
30/08/2024
InstitutionPharmaceutical company

Networks

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

Contact details

Joan Fortuny

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
Study protocol
Initial protocol

glpg0634-cl-413-protocol-redacted

English (6.07 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)