A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Drug: Etanercept; Drug: Tocilizumab

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 3080 patients were enrolled from 353 sites, across 31 countries

Reporting Groups

	Description
Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Participant Flow:   Overall Study

	Tocilizumab	Etanercept
STARTED	1538	1542
COMPLETED	1482	1475
NOT COMPLETED	56	67
Death	30	34
Lost to Follow-up	3	1
Info not recorded	10	16
Withdrawal by Subject	13	16

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
Total	Total of all reporting groups

Baseline Measures

	Tocilizumab	Etanercept	Total
Overall Participants Analyzed; [Units: Participants]	1538	1542	3080
Age; [Units: Years]; Mean (Standard Deviation)	60.7 (7.4)	60.7 (7.6)	60.7 (7.5)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	1193 77.6%	1202 78.0%	2395 77.8%
Male	345 22.4%	340 22.0%	685 22.2%

  Outcome Measures

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1. Primary:

Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event [ Time Frame: From baseline up to 4.9 years ]

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2. Primary:

Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event [ Time Frame: From baseline up to 4.9 years ]

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3. Primary:

Time to First CV-EAC Adjudicated Event - Sensitivity Analysis [ Time Frame: From Baseline up to 4.9 years ]

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4. Primary:

Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis [ Time Frame: From Baseline up to 4.9 years ]

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5. Primary:

Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis [ Time Frame: From baseline up to 4.9 years ]

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6. Primary:

Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis [ Time Frame: From baseline up to 4.9 years ]

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7. Primary:

Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date [ Time Frame: From Baseline up to 4.9 years ]

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8. Primary:

Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date [ Time Frame: From Baseline up to 4.9 years ]

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9. Secondary:

The Time to First Occurrence of an Expanded CV Composite Endpoint [ Time Frame: From baseline up to 4.9 years ]

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10. Secondary:

Percentages of Participants With an Expanded CV Composite Endpoint [ Time Frame: From baseline up to 4.9 years ]

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11. Secondary:

Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction [ Time Frame: From baseline up to 4.9 years ]

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12. Secondary:

Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction [ Time Frame: From baseline up to 4.9 years ]

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13. Secondary:

Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death [ Time Frame: From baseline up to 4.9 years ]

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14. Secondary:

Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death [ Time Frame: From baseline up to 4.9 years ]

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15. Secondary:

Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Stroke [ Time Frame: From baseline up to 4.9 years ]

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16. Secondary:

Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke [ Time Frame: From baseline up to 4.9 years ]

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17. Secondary:

Time to First Occurrence of Individual Component of Primary Endpoint: All-cause Mortality [ Time Frame: From baseline up to 4.9 years ]

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18. Secondary:

Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality [ Time Frame: From baseline up to 4.9 years ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact:  

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01331837 History of Changes
Other Study ID Numbers:	WA25204; 2010-020065-24 ( EudraCT Number )
First Submitted:	April 7, 2011
First Posted:	April 8, 2011
Results First Submitted:	March 24, 2017
Results First Posted:	July 13, 2017
Last Update Posted:	July 13, 2017