An active surveillance, post-authorization safety study (PASS) 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 British Society for Rheumatology Biologics Register-Rheumatoid Arthritis (BSRBR-RA) (Safety of tofacitinib in BSRBR-RA)

05/09/2019
02/07/2024
EU PAS number:
EUPAS31126
Study
Ongoing

ENCePP Code of conduct

No
Data sources

Data source(s)

Data source(s), other

BSRBR - Rheumatic and Musculoskeletal conditions

Data sources (types)

Disease registry
Other

Data sources (types), other

Prospective patient-based data collection, Prescription event monitoring
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No