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A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01195272
First received: September 2, 2010
Last updated: November 11, 2014
Last verified: November 2014
Results First Received: October 17, 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 (maximum dose 800 mg) intravenously (IV), once every 4 weeks up to 52 weeks (total of 13 infusions).

Participant Flow:   Overall Study
    Tocilizumab 8 Milligrams Per Kilogram (mg/kg)  
STARTED     21  
COMPLETED     17  
NOT COMPLETED     4  
Adverse Event                 1  
Lack of Efficacy                 3  



  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.
Safety Population: all participants who received at least 1 dose of tocilizumab treatment and had at least 1 post-baseline safety assessment.

Reporting Groups
  Description
Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).

Baseline Measures
    Tocilizumab 8 mg/kg  
Number of Participants  
[units: participants]
  21  
Age  
[units: Years]
Mean ± Standard Deviation
  49.2  ± 11.2  
Gender  
[units: participants]
 
Female     18  
Male     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis   [ Time Frame: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) ]

2.  Primary:   Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)   [ Time Frame: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) ]

3.  Primary:   Mean Fluorescence Intensity of CD11b on Neutrophil Surface   [ Time Frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) ]

4.  Primary:   Mean Fluorescence Intensity of CD18 on Neutrophil Surface   [ Time Frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) ]

5.  Primary:   Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface   [ Time Frame: Visits 2, 3 and 5 (Baseline and Weeks 4 and 12) ]

6.  Primary:   Mean Fluorescence Intensity of CD63 on Neutrophil Surface   [ Time Frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) ]

7.  Primary:   Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface   [ Time Frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) ]

8.  Primary:   Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface   [ Time Frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12) ]

9.  Primary:   Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation   [ Time Frame: Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24) ]

10.  Primary:   Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation   [ Time Frame: Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24) ]

11.  Primary:   Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake   [ Time Frame: Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) ]

12.  Primary:   Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation   [ Time Frame: Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24) ]

13.  Secondary:   Disease Activity Score Based on 28-Joint Count (DAS28)   [ Time Frame: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52 ]

14.  Secondary:   Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments   [ Time Frame: Weeks 12, 24, and 36 ]


  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: NCT01195272     History of Changes
Other Study ID Numbers: ML25243, 2010-018331-18
Study First Received: September 2, 2010
Results First Received: October 17, 2014
Last Updated: November 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency