An Active Surveillance, Post Authorization Safety Study (PASS) to Estimate Incidence Rates of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of Interest among all Patients Treated with Ruxience for Rheumatoid Arthritis (RA) within the British Society for Rheumatology Biologics Register Rheumatoid Arthritis (BSRBR RA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41909
• EU PAS number:
  EUPAS37688
• Study ID:
  41909
• Official title and acronym:
  An Active Surveillance, Post Authorization Safety Study (PASS) to Estimate Incidence Rates of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of Interest among all Patients Treated with Ruxience for Rheumatoid Arthritis (RA) within the British Society for Rheumatology Biologics Register Rheumatoid Arthritis (BSRBR RA)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To estimate incidence rates of infections, including serious infections, malignancies, cardiovascular events, and events associated with use during pregnancy among patients with rheumatoid arthritis in the BSRBR-RA who initiate Ruxience.
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

University of Manchester

United Kingdom

Centre for Musculosketal Research, University of Manchester

Study timelines

Date when funding contract was signed

Actual: 14/10/2020

Study start date

Planned: 31/05/2021

Actual: 31/05/2021

Data analysis start date

Planned: 31/12/2023

Date of final study report

Planned: 22/02/2024

Actual: 03/03/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc.

Study protocol

Initial protocol

B3281011_PROTOCOL AND APPROVAL_BSRBR PASS Ruxience_V1.0_ 14OCT2020

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable