Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases (EUPAS16133)

Study identification

• EU PAS number:
  EUPAS16133
• Study ID:
  50684
• Official title and acronym:
  Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases (EUPAS16133)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This retrospective cohort study will analyze data from multiple large U.S. health insurance claims databases to compare use of tocilizumab to other biologic disease modifying anti-rheumatic drugs (DMARDs) in real world patients with RA. Using the date of dispensing as the index date, the analysis will compute the time to first event for several cardiovascular outcomes.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:12/08/2015

Study start date

Actual:02/06/2016

Data analysis start date

Actual:02/06/2016

Date of final study report

Planned:15/01/2018

Actual:03/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

GA30048