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
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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 ]

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
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Time Frame Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Additional Description Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety 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.

Serious Adverse Events
    Tocilizumab 8 mg/kg     Adalimumab 40 mg  
Total, serious adverse events      
# participants affected / at risk     19/162 (11.73%)     16/162 (9.88%)  
Cardiac disorders      
Myocardial infarction † 1    
# participants affected / at risk     1/162 (0.62%)     2/162 (1.23%)  
Atrial fibrillation † 1    
# participants affected / at risk     1/162 (0.62%)     1/162 (0.62%)  
Acute coronary syndrome † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Atrial flutter † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Cardiac failure congestive † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Gastrointestinal disorders      
Enterocolitis † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Haemorrhoids † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
General disorders      
Malaise † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Sudden death † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Systemic inflammatory response syndrome † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Infections and infestations      
Cellulitis † 1    
# participants affected / at risk     0/162 (0.00%)     2/162 (1.23%)  
Appendicitis perforated † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Haematoma infection † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Infective tenosynovitis † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Parotitis † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Postoperative abscess † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Sinusitis † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Urinary tract infection † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Urosepsis † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Vestibular neuronitis † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Viral labyrinthitis † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Injury, poisoning and procedural complications      
Hip fracture † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Overdose † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Diabetes mellitus † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Musculoskeletal and connective tissue disorders      
Rheumatoid arthritis † 1    
# participants affected / at risk     3/162 (1.85%)     1/162 (0.62%)  
Back pain † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Fibromyalgia † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Intervertebral disc protusion † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Breast cancer † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Nervous system disorders      
Cerebrovascular accident † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Ischaemic stroke † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Transient ischaemic attack † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Reproductive system and breast disorders      
Cervical dysplasia † 1    
# participants affected / at risk     0/162 (0.00%)     1/162 (0.62%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea † 1    
# participants affected / at risk     1/162 (0.62%)     0/162 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (14.1)




  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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