Rheumatoid Arthritis Clinical Trial
Official title:
Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases
NCT number | NCT02797769 |
Other study ID # | GA30048 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2, 2016 |
Est. completion date | June 2, 2016 |
Verified date | January 2023 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 48950 |
Est. completion date | June 2, 2016 |
Est. primary completion date | June 2, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
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;6 — View 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: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies | Up to approximately 1 year from index date | ||
Secondary | Time to Hospitalization for Coronary Revascularization Procedure | Up to approximately 1 year from index date | ||
Secondary | Time to Hospitalization for Acute Coronary Syndrome (ACS) | Up to approximately 1 year from index date | ||
Secondary | Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS | Up to approximately 1 year from index date | ||
Secondary | Time to Heart Failure (HF) Requiring Hospitalization | Up to approximately 1 year from index date | ||
Secondary | Time to All-Cause Death | Up to approximately 1 year from index date |
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