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A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01119859
First received: April 1, 2010
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
Results First Received: September 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Tocilizumab
Drug: Adalimumab
Drug: Placebo to tocilizumab
Drug: Placebo to adalimumab

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tocilizumab 8 mg/kg Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
Adalimumab 40 mg Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.

Participant Flow:   Overall Study
    Tocilizumab 8 mg/kg   Adalimumab 40 mg
STARTED   163   163 
COMPLETED   139   133 
NOT COMPLETED   24   30 
Adverse Event                9                10 
Death                2                0 
Insufficient therapeutic response                7                14 
Refused treatment                3                6 
Failure to return                3                0 



  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.
No text entered.

Reporting Groups
  Description
Tocilizumab 8 mg/kg Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
Adalimumab 40 mg Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Tocilizumab 8 mg/kg   Adalimumab 40 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 163   162   325 
Age [1] 
[Units: Years]
Mean (Standard Deviation) 		 54.4  (12.95)   53.3  (12.43)   53.9  (12.67) 
[1]

Baseline Characteristics were analyzed for the intent-to-treat (ITT) population which included all randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

One randomized patient in the adalimumab treatment group did not receive treatment and was not included in any of the data analyses, including demographics.
Gender [1] 
[Units: Participants]
 		     
Female   129   133   262 
Male   34   29   63 
[1]

Baseline Characteristics were analyzed for the intent-to-treat (ITT) population which included all randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

One randomized patient in the adalimumab treatment group did not receive treatment and was not included in any of the data analyses, including demographics.


  Outcome Measures
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1.  Primary:   Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24   [ Time Frame: Week 24 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
Measure Description The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.
Time Frame Week 24  

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.
Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.

Reporting Groups
  Description
Tocilizumab 8 mg/kg Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
Adalimumab 40 mg Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.

Measured Values
   Tocilizumab 8 mg/kg   Adalimumab 40 mg 
Participants Analyzed 
[Units: Participants]
 		 163   162 
Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 
[Units: Percentage of patients]
 		 39.9   10.5 

No statistical analysis provided for Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24



3.  Secondary:   Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 6


  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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