Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01468077
First received: November 7, 2011
Last updated: July 20, 2015
Last verified: July 2015
Results First Received: June 23, 2015  
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

  Participant Flow
  Hide Participant Flow

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, Normal Administration Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
Tocilizumab, Fast Administration Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.

Participant Flow:   Overall Study
    Tocilizumab, Normal Administration   Tocilizumab, Fast Administration
STARTED   22   25 
COMPLETED   18   22 
NOT COMPLETED   4   3 
Adverse Event                2                2 
Lack of Efficacy                1                1 
Physician Decision                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.

Reporting Groups
  Description
Tocilizumab, Normal Administration Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
Tocilizumab, Fast Administration Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
Total Total of all reporting groups

Baseline Measures
   Tocilizumab, Normal Administration   Tocilizumab, Fast Administration   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   25   47 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (11.8)   59.8  (13.1)   58.7  (12.4) 
Gender 
[Units: Participants]
     
Female   17   20   37 
Male   5   5   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Any Infusion Reaction   [ Time Frame: Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20 ]

2.  Secondary:   Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)   [ Time Frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24 ]

3.  Secondary:   Percentage of Participants Discontinuing Tocilizumab for Other Reasons   [ Time Frame: Baseline and Weeks, 4, 8, 12, 16, 20, and 24 ]

4.  Secondary:   Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]

5.  Secondary:   Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits   [ Time Frame: Screening and Weeks 4, 8, 12, 16, 20, and 24 ]

6.  Secondary:   Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

7.  Secondary:   Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

8.  Secondary:   Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

9.  Secondary:   DAS28 Score by Visit Among Participants Who Completed All Visits   [ Time Frame: Baseline, Weeks, 4, 8, 12, 16, 20, and 24 ]

10.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

11.  Secondary:   Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits   [ Time Frame: Weeks, 4, 8, 12, 16, 20, and 24 ]

12.  Secondary:   Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits   [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]

13.  Secondary:   Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits   [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]

14.  Secondary:   High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits   [ Time Frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]

15.  Secondary:   Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, and 24 ]

16.  Secondary:   Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits   [ Time Frame: Weeks 4, 8. 12, 20, and 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01468077     History of Changes
Other Study ID Numbers: ML27901
Study First Received: November 7, 2011
Results First Received: June 23, 2015
Last Updated: July 20, 2015
Health Authority: Denmark: Danish Medicines Agency