Study identification

PURI

https://redirect.ema.europa.eu/resource/48898

EU PAS number

EUPAS46852

Study ID

48898

Official title and acronym

Non-interventional post-authorization cohort safety study evaluating the effectiveness of the additional risk minimization measures for filgotinib (Jyseleca®) use in patients with moderate to severe active rheumatoid arthritis within European registries

DARWIN EU® study

No

Study countries

Denmark
Germany
Spain
Sweden
United Kingdom

Study description

Additional risk minimization measures (aRMMs) are in place to mitigate important identified and potential risks associated with the use of filgotinib. These include a healthcare professional (HCP) guide designed to increase awareness among HCPs by delivering specific information on contraindications and warnings, and a patient alert card to enhance awareness of risks and early signs and symptoms relating to specific adverse drug reactions and the best course of action to take. To evaluate the effectiveness of aRMMs and to describe filgotinib use in real-world clinical settings, a drug utilization study will be implemented using a non-interventional follow-up (cohort) design with secondary use of data collected from 5 European rheumatoid arthritis (RA) registries from Sweden (ARTIS), Spain (BIOBADASER), the UK (BSRBR-RA), Denmark (DANBIO), Germany (RABBIT).

Study status

Ongoing
Research institution and networks

Institutions

Galapagos
First published:
01/02/2024
Institution
Karolinska Institutet
Sweden
First published:
01/02/2024
Institution
Educational Institution
BSRBR - Rheumatic and Musculoskeletal Conditions, Manchester, UK, DANBIO – Dansk Reumatologisk Database Glostrup, Denmark, BIOBADASER Madrid, Spain

Networks

ARTIS, BSRBR, DANBIO, RABBIT

Contact details

Galapagos NV Study Director

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Galapagos NV
Study protocol
Initial protocol

glpg0634-cl-408-protocol-redacted

English (5.29 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)