RISK OF CARDIOVASCULAR EVENTS IN PATIENTS USING TOCILIZUMAB AS COMPARED WITH OTHER BIOLOGICS IN MULTIPLE LARGE HEALTHCARE DATABASES (EUPAS11327)

Study identification

• EU PAS number:
  EUPAS11327
• Study ID:
  11328
• Official title and acronym:
  RISK OF CARDIOVASCULAR EVENTS IN PATIENTS USING TOCILIZUMAB AS COMPARED WITH OTHER BIOLOGICS IN MULTIPLE LARGE HEALTHCARE DATABASES (EUPAS11327)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The overall research question of the proposed study is to quantify or refute any residual cardiovascular risk that the use of Tocilizumab (TCZ) may cause in patients with RA using observational methods in large healthcare databases. The primary exposure cohort is TCZ initiators while the comparator cohort is TNF inhibitors. The primary outcome of interest is a composite of non-fatal MI and non-fatal stroke (hemorrhagic, ischemic, uncertain classification). Non-fatal MI or non-fatal stroke is defined as events where patients were hospitalized with the occurrence of death shortly after arrival. The primary analysis is an as-treated propensity score matched comparison on risk measures for the primary outcome. This study will utilize healthcare administrative claims data from multiple private and public funded healthcare insurance plans in the United States.
• Study status:
  Planned

Research institutions and networks

Institutions

Division of Pharmacoepidemiology and Pharmacoeconomics Boston

Study timelines

Date when funding contract was signed

Actual:15/06/2015

Study start date

Planned:30/11/2015

Date of final study report

Planned:30/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche/Genentech

Regulatory

• Was the study required by a regulatory body?:
  No