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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-02

Study Completion Date

2016-06-02

Brief Summary

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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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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-TNFi Biologics

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

Other Biologics

Intervention Type 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.

TNFi Biologics

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

Other Biologics

Intervention Type 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

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

Tocilizumab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Actemra

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No