Clinical trial NCT02797769: A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)
Official title: Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-06-13
Enrollment: 48950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor (TNFi) Therapies
timeFrame: Up to approximately 1 year from index date
Secondary outcomes:
measure: Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies
timeFrame: Up to approximately 1 year from index date
measure: Time to Hospitalization for Coronary Revascularization Procedure
timeFrame: Up to approximately 1 year from index date
measure: Time to Hospitalization for Acute Coronary Syndrome (ACS)
timeFrame: Up to approximately 1 year from index date
measure: Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS
timeFrame: Up to approximately 1 year from index date
measure: Time to Heart Failure (HF) Requiring Hospitalization
timeFrame: Up to approximately 1 year from index date
measure: Time to All-Cause Death
timeFrame: Up to approximately 1 year from index date
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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: 10.1016/j.semarthrit.2018.03.012. Epub 2018 Mar 22.
citation: 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.