A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00887341
First received: April 22, 2009
Last updated: October 20, 2014
Last verified: October 2014
Results First Received: June 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Drug: tocilizumab [RoActemra/Actemra]

  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, 1 Hour Infusions Participants received tocilizumab 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
Tocilizumab, 31 Minute Infusions Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.

Participant Flow:   Overall Study
    Tocilizumab, 1 Hour Infusions     Tocilizumab, 31 Minute Infusions  
STARTED     37     39  
COMPLETED     35     36  
NOT COMPLETED     2     3  
Refused treatment                 1                 0  
Withdrawal by Subject                 1                 1  
Adverse Event                 0                 1  
Lost to Follow-up                 0                 1  



  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.
Intent-to-treat (ITT) Population: all participants enrolled in the study who had been randomly assigned to one of the two study treatments and received at least one dose of study drug.

Reporting Groups
  Description
Tocilizumab, 1 Hour Infusions Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
Tocilizumab, 31 Minute Infusions Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
Total Total of all reporting groups

Baseline Measures
    Tocilizumab, 1 Hour Infusions     Tocilizumab, 31 Minute Infusions     Total  
Number of Participants  
[units: participants]
  37     39     76  
Age  
[units: years]
Mean ± Standard Deviation
  52.65  ± 12.71     52.46  ± 10.47     52.55  ± 11.54  
Gender  
[units: participants]
     
Female     35     28     63  
Male     2     11     13  



  Outcome Measures
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1.  Primary:   Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion   [ Time Frame: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24 ]

2.  Secondary:   Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

3.  Secondary:   Percentage of Participants Discontinuing Tocilizumab for Any Reason   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

4.  Secondary:   Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

5.  Secondary:   Percentage of Participants Achieving a DAS28 Score <3.2 by Visit   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

6.  Secondary:   Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

7.  Secondary:   DAS28 Score by Visit   [ Time Frame: Weeks 4, 8, 12, 16, 20, and Final Visit ]

8.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

9.  Secondary:   Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

10.  Secondary:   Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

11.  Secondary:   Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]

12.  Secondary:   C-Reactive Protein (CRP) Levels   [ Time Frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit ]

13.  Secondary:   Erythrocyte Sedimentation Rate   [ Time Frame: Baseline, Weeks 2, 4, 8, 12,16, 20, and 24 ]

14.  Secondary:   HAQ-DI Score by Visit   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24 ]

15.  Secondary:   Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI   [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ]


  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: Hoffmann- LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00887341     History of Changes
Other Study ID Numbers: ML22254, 2008-006443-39
Study First Received: April 22, 2009
Results First Received: June 26, 2014
Last Updated: October 20, 2014
Health Authority: Spain: Ministry of Health