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

January 20, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48950

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Real world patients with RA who received tocilizumab or other biologic therapy will be included. Data will be collected from multiple large U.S. health insurance claims databases in this retrospective cohort analysis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-TNFi Biologics
Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included.
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.
TNFi Biologics
Real world patients with RA with a dispensing history for TNFi biologics will be included.
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
Real world patients with RA with a dispensing history for tocilizumab will be included.
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.
Other Names:
  • Actemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to approximately 1 year from index date

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2016

Primary Completion (Actual)

June 2, 2016

Study Completion (Actual)

June 2, 2016

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA30048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Other Biologics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe