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Completed

NCT Number: NCT02797769

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 1 inpatient or 2 outpatient diagnoses of RA
  • Continuous medical/pharmacy coverage and full claims data available
  • At least 6 months of insurance plan enrollment prior to index date

Exclusion criteria

  • Nursing home residents
  • Human immunodeficiency virus (HIV)
  • Malignancy
  • Receipt of chemotherapy
  • End-stage renal disease, dialysis, or transplant
  • Use of rituximab
  • Recent cardiovascular event (includes MI, stroke, ACS, or HF) within 90 days prior to index date

Treatment and study plan

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.

Other names: Actemra

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies

    Time frame: Up to approximately 1 year from index date

  2. Time to Hospitalization for Coronary Revascularization Procedure

    Time frame: Up to approximately 1 year from index date

  3. Time to Hospitalization for Acute Coronary Syndrome (ACS)

    Time frame: Up to approximately 1 year from index date

  4. Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS

    Time frame: Up to approximately 1 year from index date

  5. Time to Heart Failure (HF) Requiring Hospitalization

    Time frame: Up to approximately 1 year from index date

  6. Time to All-Cause Death

    Time frame: Up to approximately 1 year from index date

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 13, 2016
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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