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A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00810277
First received: December 16, 2008
Last updated: March 1, 2016
Last verified: March 2016
Results First Received: March 1, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group 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
No text entered.

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 Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.

Participant Flow:   Overall Study
    Tocilizumab
STARTED   14 
COMPLETED   13 
NOT COMPLETED   1 
Adverse Event                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.
Analysis population included all participants who entered the study.

Reporting Groups
  Description
Tocilizumab Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.

Baseline Measures
   Tocilizumab 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.86  (9.662) 
Gender 
[Units: Participants]
 
Female   11 
Male   3 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Week 24 ]

2.  Secondary:   Disease Activity Score (DAS28)   [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]

3.  Secondary:   Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

5.  Secondary:   C-Reactive Protein (CRP) Level   [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]

6.  Secondary:   Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]

7.  Secondary:   Percentage of Participants Who Discontinued the Study   [ Time Frame: Up to Week 24 ]

8.  Secondary:   Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal   [ Time Frame: Up to Week 24 ]

9.  Secondary:   Percentage of Participants With Lipid Level Elevations   [ Time Frame: Week 24 ]

10.  Secondary:   Neutrophil Count   [ Time Frame: Baseline, Weeks 4, 8, and 12 ]


  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-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00810277     History of Changes
Other Study ID Numbers: ML22012
2008-004126-16
Study First Received: December 16, 2008
Results First Received: March 1, 2016
Last Updated: March 1, 2016
Health Authority: Finland: Finnish Medicines Agency