Study identification

PURI

https://redirect.ema.europa.eu/resource/48895

EU PAS number

EUPAS46856

Study ID

48895

Official title and acronym

Non-interventional post-authorization safety study of filgotinib in the treatment of 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

Filgotinib is a JAK1 preferential inhibitor for the treatment of moderate/severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARD). Randomized clinical trials (RCTs) have provided information on filgotinib’s efficacy and safety. However, for assessing safety RCT designs have limitations, e.g. restrictive eligibility criteria, sample sizes and follow-up. Long term safety data are thus needed in patients treated with filgotinib in real world clinical settings. European RA registries have been established to evaluate the safety profiles of numerous DMARDs and used to address post-authorization safety requirements. This non-interventional postauthorization safety study aims to evaluate the long-term safety of filgotinib in RA by making secondary use of data collected by registries from Sweden (ARTIS), Spain (BIOBADASER), UK (BSRBRRA), Denmark (DANBIO) and Germany (RABBIT).

Study status

Ongoing
Research institutions and networks

Institutions

Alfasigma
Italy
First published:
30/08/2024
InstitutionPharmaceutical company
Karolinska Institutet
Sweden
First published:
01/02/2024
InstitutionEducational Institution
BSRBR - Rheumatic and Musculoskeletal Conditions Manchester, UK
DANBIO – Dansk Reumatologisk Database Glostrup, Denmark
BIOBADASER Madrid, Spain

Networks

ARTIS, BSRBR, DANBIO, RABBIT

Contact details

Raymond Schlienger

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

Alfasigma S.p.A
Study protocol
Initial protocol

glpg0634-cl-403-protocol-redacted

English (7.2 MB - PDF)View document
Updated protocol

glpg0634-cl-403-protocol V2_Redacted.pdf

English (8.43 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)