Rheumatoid ArthritisNCT02797769
A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Other Biologics and Tocilizumab
- How many people
- 48,950 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2016to 2 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Other Biologics, Tocilizumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
TocilizumabDrug
Also called Actemra
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-TNFi Biologics | Real world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included. Receives: Drug: Other Biologics | |
| TNFi Biologics | Real world patients with RA with a dispensing history for TNFi biologics will be included. Receives: Drug: Other Biologics | |
| Tocilizumab | Real world patients with RA with a dispensing history for tocilizumab will be included. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor (TNFi) Therapies
Measured: 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
Measured: Up to approximately 1 year from index date
Time to Hospitalization for Coronary Revascularization Procedure
Measured: Up to approximately 1 year from index date
Time to Hospitalization for Acute Coronary Syndrome (ACS)
Measured: Up to approximately 1 year from index date
Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS
Measured: Up to approximately 1 year from index date
Time to Heart Failure (HF) Requiring Hospitalization
Measured: Up to approximately 1 year from index date
Time to All-Cause Death
Measured: Up to approximately 1 year from index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start2 Jun 2016
- Primary completion2 Jun 2016
- Study completion2 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797769
- Sponsor's protocol ID
- GA30048
- Status last verified
- Jan 2023
- First submitted
- 8 Jun 2016
- Last updated
- 25 Jan 2023
- Results posted
- No
Publications
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.
PubMed 29673963Kim 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.
PubMed 28245350
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases
- ClinicalTrials.gov ID
- NCT02797769
- Acronym / sponsor ID
- GA30048
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48,950 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 2 Jun 2016 (actual)
- Study completion
- 2 Jun 2016 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-TNFi Biologics | – | Drug: Other BiologicsReal world patients with RA with a dispensing history for non-TNFi biologics (such as abatacept or tofacitinib) will be included. |
| TNFi Biologics | – | Drug: Other BiologicsReal world patients with RA with a dispensing history for TNFi biologics will be included. |
| Tocilizumab | – | Drug: TocilizumabReal world patients with RA with a dispensing history for tocilizumab will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Nursing home residents
- Human immunodeficiency virus (HIV)
- Malignancy
- Receipt of chemotherapy
- End-stage renal disease, dialysis, or transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other BiologicsExposure 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. | Drug | Non-TNFi Biologics, TNFi Biologics |
| TocilizumabAlso: ActemraTocilizumab 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. | Drug | Tocilizumab |
Primary outcome
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
6 secondary outcomes
Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies
Time frame: Up to approximately 1 year from index date
Time to Hospitalization for Coronary Revascularization Procedure
Time frame: Up to approximately 1 year from index date
Time to Hospitalization for Acute Coronary Syndrome (ACS)
Time frame: Up to approximately 1 year from index date
Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS
Time frame: Up to approximately 1 year from index date
Time to Heart Failure (HF) Requiring Hospitalization
Time frame: Up to approximately 1 year from index date
Time to All-Cause Death
Time frame: Up to approximately 1 year from index date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Results publication: PubMed 29673963Kim 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.
- Results publication: PubMed 28245350Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02797769, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.