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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797769
• Other study ID #: GA30048
• Status: Completed
• Start date: June 2, 2016
• Est. completion date: June 2, 2016

Study information

• Verified date: January 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48950
• Est. completion date: June 2, 2016
• Est. primary completion date: June 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Other Biologics
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

References & Publications (2)

Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, Schneeweiss S. Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients With Rheumatoid Arthritis: A Multi-Database Cohort Study. Arthritis Rheumatol. 2017 Jun;6 — View Citation

Kim SC, Solomon DH, Rogers JR, Gale S, Klearman M, Sarsour K, Schneeweiss S. No difference in cardiovascular risk of tocilizumab versus abatacept for rheumatoid arthritis: A multi-database cohort study. Semin Arthritis Rheum. 2018 Dec;48(3):399-405. doi: — View Citation

Outcome

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