Non-interventional post-authorization safety study of filgotinib in the treatment of patients with moderate to severe active rheumatoid arthritis within European registries

Study identification

• 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

Epidemiology Unit, Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)

Germany

British Society for Rheumatology Biologics Registers (BSRBR)

Karolinska Institutet

Sweden

BSRBR - Rheumatic and Musculoskeletal Conditions Manchester, UK
DANBIO – Dansk Reumatologisk Database Glostrup, Denmark
BIOBADASER Madrid, Spain

Networks

Registro Español de Acontecimientos Adversos de Terapias Biológicas en Pacientes Reumáticos (BIOBADASER)

Spain

ARTIS, BSRBR, DANBIO, RABBIT

Study timelines

Date when funding contract was signed

Actual:14/12/2021

Study start date

Actual:29/12/2021

Date of final study report

Planned:01/07/2031

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)

Other study registration identification numbers and links

GLPG0634-CL-403