NCT02797769

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48,950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

June 8, 2016

Last Update Submit

January 20, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

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

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

Interventions

Other BiologicsDRUG

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.

Non-TNFi BiologicsTNFi Biologics
TocilizumabDRUG

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.

Also known as: Actemra
Tocilizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 10.1016/j.semarthrit.2018.03.012. Epub 2018 Mar 22.

    PMID: 29673963RESULT

  • 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;69(6):1154-1164. doi: 10.1002/art.40084. Epub 2017 Apr 28.

    PMID: 28245350RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 13, 2016

Study Start

June 2, 2016

Primary Completion

June 2, 2016

Study Completion

June 2, 2016

Last Updated

January 25, 2023

Record last verified: 2023-01