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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Other Biologics; Drug: Tocilizumab

• Registration Number: NCT02797769
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-02
• Primary Completion: 2016-06-02
• Study Completion: 2016-06-02
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-13
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48950

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies	Up to approximately 1 year from index date
Time to Hospitalization for Coronary Revascularization Procedure	Up to approximately 1 year from index date
Time to Hospitalization for Acute Coronary Syndrome (ACS)	Up to approximately 1 year from index date
Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS	Up to approximately 1 year from index date
Time to Heart Failure (HF) Requiring Hospitalization	Up to approximately 1 year from index date
Time to All-Cause Death	Up to approximately 1 year from index date