Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000034

EU PAS number

EUPAS1000000034

Study ID

1000000034

Official title and acronym

Long-term real-world safety of ozanimod – A post-authorisation safety study (PASS) in patients diagnosed with ulcerative colitis

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Netherlands
Norway
United Kingdom

Study description

This post-authorization safety study (PASS) will collect data in participants diagnosed with ulcerative colitis initiating therapy with ozanimod or advanced therapies. Data will be collected from different databases and registries in European countries and in the UK (Denmark, Germany, Netherlands, Norway, England, Scotland, France).

Study status

Ongoing
Research institutions and networks

Institutions

University of Dundee
United Kingdom
First published:
01/02/2024
InstitutionEducational Institution
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

Networks

The SIGMA Consortium (SIGMA)
Denmark
European Union
France
Germany
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
First published:
16/12/2024
Network
ENCePP partner

Contact details

Nicole Baker

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

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

Bristol-Myers Squibb (BMS) 100%
Study protocol
Initial protocol

IM047-1037_Redacted Protocol.pdf

English (10.66 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)