Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00361634
First received: August 4, 2006
Last updated: July 10, 2013
Last verified: July 2013
Results First Received: August 13, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Drug: Etanercept

  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
Participants were enrolled from 13 December 2006 through 27 April 2009

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
Etanercept Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.

Participant Flow:   Overall Study
    Etanercept  
STARTED     14  
Treated     13 [1]
COMPLETED     12  
NOT COMPLETED     2  
Lost to Follow-up                 1  
Withdrawal by Subject                 1  
[1] The safety analysis set consisted of all patients who received at least one dose of etanercept.



  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.
No text entered.

Reporting Groups
  Description
Etanercept Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
  14  
Age  
[units: Years]
Mean ± Standard Deviation
  50.6  ± 14.3  
Gender  
[units: Participants]
 
Female     13  
Male     1  
Race/Ethnicity, Customized  
[units: Participants]
 
White or Caucasian     8  
Black or African American     1  
Hispanic or Latino     4  
Other     1  



  Outcome Measures
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1.  Primary:   Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-29   [ Time Frame: Day 1 to Day 29 ]

2.  Primary:   Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-57   [ Time Frame: Day 1 to Day 57 ]

3.  Primary:   Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-85   [ Time Frame: Day 1 to Day 85 ]

4.  Primary:   Percent Change in Synovial Initial Area Under the (Contrast-time) Curve (IAUC) From Days 1-29   [ Time Frame: Day 1 to Day 29 ]

5.  Primary:   Percent Change in the Synovial Initial Area Under the Contrast-Tme Curve (IAUC) From Days 1-57   [ Time Frame: Day 1 to Day 57 ]

6.  Primary:   Percent Change in the Synovial Initial Area Under the Contrast-Time Curve (IAUC) From Days 1-85   [ Time Frame: Day 1 to Day 85 ]

7.  Secondary:   Percent Change in Synovial Volume From Days 1-29   [ Time Frame: Day 1 to Day 29 ]

8.  Secondary:   Percent Change in Synovial Volume From Days 1-57   [ Time Frame: Day 1 to Day 57 ]

9.  Secondary:   Percent Change in Synovial Volume From Days 1-85   [ Time Frame: Day 1 to Day 85 ]

10.  Secondary:   Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 29   [ Time Frame: Day -28 to Day 29 ]

11.  Secondary:   Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 57   [ Time Frame: Day -28 to Day 57 ]

12.  Secondary:   Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 85   [ Time Frame: Day -28 to Day 85 ]

13.  Secondary:   Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 29   [ Time Frame: Day -28 to Day 29 ]

14.  Secondary:   Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 57   [ Time Frame: Day -28 to Day 57 ]

15.  Secondary:   Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 85   [ Time Frame: Day -28 to Day 85 ]


  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
No text entered.


  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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00361634     History of Changes
Other Study ID Numbers: 20060118
Study First Received: August 4, 2006
Results First Received: August 13, 2010
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration