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Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

This study has been completed.
Sponsor:
Collaborator:
Innovex, Inc
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00195338
First received: September 12, 2005
Last updated: December 16, 2011
Last verified: December 2011
Results First Received: December 16, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
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
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 Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.

Participant Flow:   Overall Study
    Etanercept  
STARTED     25  
COMPLETED     13  
NOT COMPLETED     12  
Lost to Follow-up                 2  
Adverse Event                 5  
Lack of Efficacy                 1  
Early closure of the site                 4  



  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 Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Mean ± Standard Deviation
  50.20  ± 13.93  
Gender  
[units: participants]
 
Female     20  
Male     5  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Month 66 ]

2.  Secondary:   Percentage of Participants With Completion of Study Treatment   [ Time Frame: Month 12 through Month 72 ]

3.  Secondary:   Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66   [ Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66 ]

4.  Secondary:   Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66   [ Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66 ]

5.  Secondary:   Mean Dose of Concomitant Methotrexate (MTX) and Steroids   [ Time Frame: Baseline up to Month 66 ]


  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: NCT00195338     History of Changes
Other Study ID Numbers: 0881-101343
Study First Received: September 12, 2005
Results First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: European Union: European Medicines Agency