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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02797769

Collaborator

(none)

75,000

Enrollment

17.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Other Biologics Drug: Tocilizumab

Study Design

Study Type:

Observational

Anticipated Enrollment :

75000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	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

Arm

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT02797769

Other Study ID Numbers:

GA30048

First Posted:

Jun 13, 2016

Last Update Posted:

Jul 4, 2016

Last Verified:

Jul 1, 2016

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Jul 4, 2016