Trial · NCT01331837
A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
NCT01331837, Phase 4, Completed, Hoffmann-La Roche; results first posted 2017-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors. Trials, record NCT01331837. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01331837
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
- NCT number
- NCT01331837
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 3,080 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Rheumatoid Arthritis
- Interventions
- Etanercept, Tocilizumab
- First posted
- 2011-04-08
- Last updated
- 2017-07-13
- Other registries' IDs
- eudract:2010-020065-24
- Results first posted
- 2017-07-13
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | From baseline up to 4.9 years | Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke. |
| Primary | Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | From baseline up to 4.9 years | Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke |
| Primary | Time to First CV-EAC Adjudicated Event - Sensitivity Analysis | From Baseline up to 4.9 years | Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis |
| Primary | Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis | From Baseline up to 4.9 years | Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis |
| Primary | Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis | From baseline up to 4.9 years | Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses |
| Primary | Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis | From baseline up to 4.9 years | Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses |
| Primary | Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date | From Baseline up to 4.9 years | Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call). |
| Primary | Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date | From Baseline up to 4.9 years | Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call). |
| Secondary | The Time to First Occurrence of an Expanded CV Composite Endpoint | From baseline up to 4.9 years | Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina. |
| Secondary | Percentages of Participants With an Expanded CV Composite Endpoint | From baseline up to 4.9 years | Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | From baseline up to 4.9 years | Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication | Months | MEDIAN |
| PRIMARY | Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | From baseline up to 4.9 years | Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication | Percentage of patients with event | NUMBER |
| PRIMARY | Time to First CV-EAC Adjudicated Event - Sensitivity Analysis | From Baseline up to 4.9 years | Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching. | Months | MEDIAN |
| PRIMARY | Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis | From Baseline up to 4.9 years | Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching. | Percentage of patients with event | NUMBER |
| PRIMARY | Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis | From baseline up to 4.9 years | Analysis was conducted on the ITT population | Months | MEDIAN |
| PRIMARY | Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis | From baseline up to 4.9 years | Analysis was conducted on the ITT population | Percentage of patients with event | NUMBER |
| PRIMARY | Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date | From Baseline up to 4.9 years | Analysis was conducted on the ITT population | Months | MEDIAN |
| PRIMARY | Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date | From Baseline up to 4.9 years | Analysis was conducted on the ITT population | Percentage of participants with event | NUMBER |
| SECONDARY | The Time to First Occurrence of an Expanded CV Composite Endpoint | From baseline up to 4.9 years | Analysis was conducted on the ITT population. | Months | MEDIAN |
| SECONDARY | Percentages of Participants With an Expanded CV Composite Endpoint | From baseline up to 4.9 years | Analysis was conducted on the ITT population. | Percentages of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | Tocilizumab | NA | 95% Confidence Interval NA to NA | Months | |
| Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | Etanercept | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | Tocilizumab | 5.4 | Percentage of patients with event | ||
| Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event | Etanercept | 5.1 | Percentage of patients with event | ||
| Time to First CV-EAC Adjudicated Event - Sensitivity Analysis | Tocilizumab | NA | 95% Confidence Interval NA to NA | Months | |
| Time to First CV-EAC Adjudicated Event - Sensitivity Analysis | Etanercept | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis | Tocilizumab | 3.7 | Percentage of patients with event | ||
| Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis | Etanercept | 3.4 | Percentage of patients with event | ||
| Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis | Tocilizumab | NA | 95% Confidence Interval NA | Months | |
| Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis | Etanercept | NA | 95% Confidence Interval NA | Months |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tocilizumab | 1,538 | |
| Overall Study | STARTED | Etanercept | 1,542 | |
| Overall Study | COMPLETED | Tocilizumab | 1,482 | |
| Overall Study | COMPLETED | Etanercept | 1,475 | |
| Overall Study | NOT COMPLETED | Tocilizumab | 56 | |
| Overall Study | NOT COMPLETED | Etanercept | 67 |
Source ClinicalTrials.gov
Adverse events1,236
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | LEUKOPENIA | Blood and lymphatic system disorders | Etanercept | 21 | 1,542 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Tocilizumab | 85 | 1,538 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Etanercept | 33 | 1,542 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Tocilizumab | 92 | 1,538 | |
| other | DIARRHOEA | Gastrointestinal disorders | Etanercept | 84 | 1,542 | |
| other | DIARRHOEA | Gastrointestinal disorders | Tocilizumab | 140 | 1,538 | |
| other | BRONCHITIS | Infections and infestations | Etanercept | 185 | 1,542 | |
| other | BRONCHITIS | Infections and infestations | Tocilizumab | 244 | 1,538 | |
| other | NASOPHARYNGITIS | Infections and infestations | Etanercept | 141 | 1,542 | |
| other | NASOPHARYNGITIS | Infections and infestations | Tocilizumab | 239 | 1,538 |
1 to 10 of 1,236Source ClinicalTrials.gov
See all 1,236 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | ||
| Total, all-cause mortality | Tocilizumab | ||
| Total, other adverse events | Etanercept | 910 | 1,542 |
| Total, other adverse events | Tocilizumab | 1,090 | 1,538 |
| Total, serious adverse events | Etanercept | 422 | 1,542 |
| Total, serious adverse events | Tocilizumab | 479 | 1,538 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31469238 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Etanercept vs Tocilizumab: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01331837
GET https://conductscience.org/api/trials/v1/NCT01331837/results?page=2