A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)

Sponsor
Hoffmann-La Roche
Study ID
NCT02797769
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Other Biologics — DRUG
    Exposure data will be gathered from claims databases, and no medicine will be administered in this non-interventional study. There are no protocol-specified biologic agents, although the analyses will be stratified by TNFi and non-TNFi targeted therapies. The drug selection and regimen are at the discretion of the prescribing physician.
  • Tocilizumab — DRUG
    Tocilizumab exposure data will be gathered from claims databases, and no medicine will be administered in this non-interventional study. The regimen is at the discretion of the prescribing physician.

Study Details

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.

Key Dates

Start date
Jun 2, 2016
Status verified
Jan 2023
Primary completion
Jun 2, 2016
Completion
Jun 2, 2016

Study Design

Enrollment
48,950 participants (actual)

Arms

  • Arm: Non-TNFi Biologics
    Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included.
  • Arm: TNFi Biologics
    Real world patients with RA with a dispensing history for TNFi biologics will be included.
  • Arm: Tocilizumab
    Real world patients with RA with a dispensing history for tocilizumab will be included.

Primary Outcome Measure

Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor (TNFi) Therapies [ Time Frame: Up to approximately 1 year from index date ]

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