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

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ClinicalTrials.gov Identifier: NCT02797769
Recruitment Status : Unknown
Verified July 2016 by Hoffmann-La Roche.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2016
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Rheumatoid Arthritis Drug: Other Biologics Drug: Tocilizumab

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Study Type : Observational
Estimated 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 : August 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

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 Name: Actemra




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies [ Time Frame: Up to approximately 1 year from index date ]
  2. Time to Hospitalization for Coronary Revascularization Procedure [ Time Frame: Up to approximately 1 year from index date ]
  3. Time to Hospitalization for Acute Coronary Syndrome (ACS) [ Time Frame: Up to approximately 1 year from index date ]
  4. Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS [ Time Frame: Up to approximately 1 year from index date ]
  5. Time to Heart Failure (HF) Requiring Hospitalization [ Time Frame: Up to approximately 1 year from index date ]
  6. Time to All-Cause Death [ Time Frame: Up to approximately 1 year from index date ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797769


Contacts
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Contact: Reference Study ID Number: GA30048 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02797769     History of Changes
Other Study ID Numbers: GA30048
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases