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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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%

1.  Primary:

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

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 ]

3.  Primary:

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

4.  Primary:

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

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 ]

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 ]

7.  Primary:

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

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 ]

9.  Secondary:

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

10.  Secondary:

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

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 ]

12.  Secondary:

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

13.  Secondary:

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

14.  Secondary:

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

15.  Secondary:

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

16.  Secondary:

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

17.  Secondary:

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

18.  Secondary:

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

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
No text entered.