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A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00848120
First received: February 19, 2009
Last updated: December 23, 2014
Last verified: December 2014
Results First Received: May 5, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   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 8 Milligrams Per Kilogram (mg/kg) Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 24 weeks.

Participant Flow:   Overall Study
    Tocilizumab 8 Milligrams Per Kilogram (mg/kg)  
STARTED     29  
COMPLETED     28  
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.

The safety population included all participants who received any part of an infusion of study drug.

Intent to Treat (ITT) Population was used for efficacy analyses. All participants who have received any part of an infusion of study medication were included in this population.


Reporting Groups
  Description
Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.

Baseline Measures
    Tocilizumab 8 mg/kg  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Mean (Standard Deviation)
  47  (14.1)  
Gender  
[units: participants]
 
Female     28  
Male     1  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR   [ Time Frame: Week 24 ]

8.  Secondary:   Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR   [ Time Frame: Week 24 ]

9.  Secondary:   Time to Onset of ACR20/50/70 Response   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]


  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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00848120     History of Changes
Other Study ID Numbers: ML22074
Study First Received: February 19, 2009
Results First Received: May 5, 2014
Last Updated: December 23, 2014
Health Authority: Philippines: Department of Health