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 German Registry Rheumatoide Arthritis: Beobachtung der Biologika Therapie (RABBIT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41900
• EU PAS number:
  EUPAS37691
• Study ID:
  41900
• 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 German Registry Rheumatoide Arthritis: Beobachtung der Biologika Therapie (RABBIT)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• 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 RABBIT register who initiate Ruxience.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Epidemiology Unit, Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)

Germany

Study timelines

Date when funding contract was signed

Actual: 01/07/2020

Study start date

Planned: 02/06/2021

Actual: 02/06/2021

Data analysis start date

Planned: 31/12/2023

Actual: 31/12/2023

Date of final study report

Planned: 30/11/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc

Study protocol

Initial protocol

B3281012_PROTOCOL AND APPROVAL_RABBIT 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