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A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01163747
First received: July 14, 2010
Last updated: November 12, 2012
Last verified: November 2012
Results First Received: November 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Biological: tocilizumab
Drug: methotrexate
Biological: 23-Valent Pneumococcal Polysaccharide Vaccine
Biological: Tetanus Toxoid Adsorbed Vaccine

  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
This study was conducted at 35 centers in the United States. Among the 112 patients screened, 91 patients were randomized in a 1:2 ratio to the methotrexate alone or to the tocilizumab + methotrexate treatment group.

Reporting Groups
  Description
Methotrexate Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
Tocilizumab + Methotrexate Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.

Participant Flow:   Overall Study
    Methotrexate     Tocilizumab + Methotrexate  
STARTED     31     60  
Per Protocol Population     27 [1]   54 [1]
COMPLETED     25     49  
NOT COMPLETED     6     11  
Adverse Event                 0                 5  
Insufficient Therapeutic Response                 0                 1  
Protocol Violation                 0                 1  
Refused Treatment                 6                 4  
[1] Participants who received at least 1 dose of study treatment excluding major protocol violators.



  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
Methotrexate Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
Tocilizumab + Methotrexate Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
Total Total of all reporting groups

Baseline Measures
    Methotrexate     Tocilizumab + Methotrexate     Total  
Number of Participants  
[units: participants]
  27     54     81  
Age [1]
[units: years]
Mean ± Standard Deviation
  51.4  ± 9.47     51.1  ± 8.90     51.2  ± 9.04  
Gender  
[units: participants]
     
Female     22     41     63  
Male     5     13     18  
Region of Enrollment  
[units: participants]
     
United States     27     54     81  
[1] Demographic data are provided for the per protocol population.



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes   [ Time Frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination) ]

2.  Secondary:   Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes   [ Time Frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination) ]

3.  Secondary:   Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination   [ Time Frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination) ]

4.  Secondary:   Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination   [ Time Frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination) ]

5.  Secondary:   Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination   [ Time Frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination) ]

6.  Secondary:   Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes   [ Time Frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination) ]

7.  Secondary:   Number of Participants With Adverse Events Through Week 8   [ Time Frame: 8 weeks ]


  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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  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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01163747     History of Changes
Other Study ID Numbers: NA25256
Study First Received: July 14, 2010
Results First Received: November 12, 2012
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration