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 Swedish, Population based, Anti Rheumatic Treatment in Sweden (ARTIS) Register

Study identification

• EU PAS number:
  EUPAS37694
• Study ID:
  41897
• 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 Swedish, Population based, Anti Rheumatic Treatment in Sweden (ARTIS) Register
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  To estimate incidence rates of infections, including serious infections, malignancies, cardiovascular events, and use during pregnancy among patients with rheumatoid arthritis in the ARTIS register who initiate Ruxience.
• Study status:
  Finalised

Research institutions and networks

Institutions

Karolinska Institutet

Sweden

Department of Rheumatology, Karolinska University Hosptial

Study timelines

Date when funding contract was signed

Actual: 16/10/2020

Study start date

Planned: 01/07/2021

Actual: 01/07/2021

Data analysis start date

Planned: 31/12/2023

Date of final study report

Planned: 30/11/2024

Actual: 17/07/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Regulatory

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