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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

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


  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 ]

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


  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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