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Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance] (Enbrel-JIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01145352
First received: June 9, 2010
Last updated: August 20, 2014
Last verified: August 2014
Results First Received: August 20, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Juvenile Idiopathic Arthritis
Intervention: Drug: Etanercept (genetical recombination)

  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
Etanercept (Genetical Recombination) Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.

Participant Flow:   Overall Study
    Etanercept (Genetical Recombination)  
STARTED     113  
COMPLETED     102  
NOT COMPLETED     11  
Found to have been registered twice                 6  
Treated before marketing approval                 4  
Syringe formulation was used                 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.
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Reporting Groups
  Description
Etanercept (Genetical Recombination) Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.

Baseline Measures
    Etanercept (Genetical Recombination)  
Number of Participants  
[units: participants]
  102  
Age, Customized  
[units: participants]
 
<5 years     1  
>= 5 to < 10 years     24  
>= 10 to < 15 years     37  
>= 15 to < 20 years     30  
>= 20 to < 30 years     10  
>=30 years     0  
Gender  
[units: participants]
 
Female     78  
Male     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-Related Adverse Events of Etanercept   [ Time Frame: 24 weeks ]

2.  Primary:   Number of Participants With Serious Treatment-Related Adverse Events of Etanercept   [ Time Frame: 24 weeks ]

3.  Primary:   Number of Unlisted Treatment-Related Adverse Events of Etanercept   [ Time Frame: 24 weeks ]

4.  Primary:   Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28   [ Time Frame: 24 weeks ]

5.  Secondary:   Percentage of Participants With Overall Improvement On Physician's Assessment.   [ Time Frame: 24 weeks ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01145352     History of Changes
Other Study ID Numbers: 0881Y1-4689, B1801130
Study First Received: June 9, 2010
Results First Received: August 20, 2014
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration