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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab; Drug: Other Biologics

Study type: Observational

Funder types: Industry

Identifiers

NCT02797769

GA30048

Details and patient eligibility

About

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.

Enrollment: 48,950 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

48,950 participants in 3 patient groups

Non-TNFi Biologics

Description:

Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included.

Treatment:

Drug: Other Biologics

TNFi Biologics

Description:

Real world patients with RA with a dispensing history for TNFi biologics will be included.

Treatment:

Drug: Other Biologics

Tocilizumab

Description:

Real world patients with RA with a dispensing history for tocilizumab will be included.

Treatment:

Drug: Tocilizumab