Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT02797769
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2016-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '29673963', 'type': 'RESULT', '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.'}, {'pmid': '28245350', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 1 inpatient or 2 outpatient diagnoses of RA\n* Continuous medical/pharmacy coverage and full claims data available\n* At least 6 months of insurance plan enrollment prior to index date\n\nExclusion Criteria:\n\n* Nursing home residents\n* Human immunodeficiency virus (HIV)\n* Malignancy\n* Receipt of chemotherapy\n* End-stage renal disease, dialysis, or transplant\n* Use of rituximab\n* Recent cardiovascular event (includes MI, stroke, ACS, or HF) within 90 days prior to index date'}, 'identificationModule': {'nctId': 'NCT02797769', 'briefTitle': 'A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases', 'orgStudyIdInfo': {'id': 'GA30048'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-TNFi Biologics', 'description': 'Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included.', 'interventionNames': ['Drug: Other Biologics']}, {'label': 'TNFi Biologics', 'description': 'Real world patients with RA with a dispensing history for TNFi biologics will be included.', 'interventionNames': ['Drug: Other Biologics']}, {'label': 'Tocilizumab', 'description': 'Real world patients with RA with a dispensing history for tocilizumab will be included.', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Other Biologics', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Non-TNFi Biologics', 'TNFi Biologics']}, {'name': 'Tocilizumab', 'type': 'DRUG', 'otherNames': ['Actemra'], 'description': '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.', 'armGroupLabels': ['Tocilizumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}