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
Results First Received: September 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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.
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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  
Number of Participants  
[units: participants]
  163     162     325  
Age [1]
[units: years]
Mean ± Standard Deviation
  54.4  ± 12.95     53.3  ± 12.43     53.9  ± 12.67  
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 ]
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Measure Type Primary
Measure Title Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
Measure Description The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).
Time Frame Baseline to Week 24  
Safety Issue No  

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  
Number of Participants Analyzed  
[units: participants]
  163     162  
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)  
[units: Units on a scale]
Mean ( 95% Confidence Interval )
  -3.3  
  ( -3.57 to -3.02 )  
  -1.8  
  ( -2.10 to -1.55 )  

No statistical analysis provided for Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)



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

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 ]

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

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 ]


  Serious Adverse Events


  Other Adverse Events


  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:
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.


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
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Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01119859     History of Changes
Other Study ID Numbers: WA19924, 2009-015845-21
Study First Received: April 1, 2010
Results First Received: September 18, 2012
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration