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

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ClinicalTrials.gov Identifier: NCT01331837
Recruitment Status : Completed
First Posted : April 8, 2011
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):

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

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 



  Baseline Characteristics

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

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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.


  More Information

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:
unchecked 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.
unchecked 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.


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