Network identification

Network ID

4915

Network name and Acronym

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

Network website

Network countries

Spain

ENCePP partner

No
Network description
BIOBADASER collects actively information on relevant adverse events occurring during the long term treatment with biologic therapies in patients suffering rheumatic diseases. The objective of the register is to identify adverse events in daily practice conditions,to estimate the risk of adverse events,and to assess the survival of the biologics in the long term. BIOBADASER is the result of a collaborative effort of the Spanish rheumatologists (100 centers in phase 1 and 14 in phase 2),the Research Unit of the Spanish Foundation for Rheumatology (FER),the Spanish Agency for Medicines and Medical Devices (AEMyPS) and the Spanish Society of Rheumatology (SER).
Network details
Network primary therapeutic area:
Musculoskeletal and joint diseases
Network funding:
Other
Pharmaceutical company and other private sector 

Contact

Institutions that are part of this network

Research Unit, Sociedad Espanola de Reumatologia (SER)

Studies conducted by the network

An active surveillance, post-authorization safety study of serious infection, malignancy, cardiovascular and other safety events of interest among patients treated with tofacitinib for moderately to severely active rheumatoid arthritis within the Spanish registry of adverse events of biological therapies and biosimilars in rheumatoid diseases (BIOBADASER) (Safety of tofacitinib in BIOBADASER)
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
Non-interventional post-authorization safety study of filgotinib in the treatment of patients with moderate to severe active rheumatoid arthritis within European registries
Post-authorization Safety Surveillance Program for Sarilumab using existing European Rheumatoid Arthritis Registries in Germany, Spain, Sweden and United Kingdom