Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

This study has been terminated.
(The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug.)
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00273858
First received: January 4, 2006
Last updated: September 8, 2011
Last verified: September 2011
Results First Received: June 30, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Ankylosing Spondylitis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Intervention: Other: There is no Intervention. The study is observational.

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Etanercept Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.

Participant Flow:   Overall Study
    Etanercept  
STARTED     880  
COMPLETED     343  
NOT COMPLETED     537  
Not completed 24 month observation time                 334  
Lost to Follow-up                 101  
Withdrawal by Subject                 21  
Adverse Event                 81  



  Baseline Characteristics
  Hide Baseline Characteristics

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 administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
  880  
Age [1]
[units: Years]
Mean ± Standard Deviation
  52.0  ± 13.6  
Gender  
[units: Participants]
 
Female     562  
Male     318  
[1] Mean age of the participants is based on N=795.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Month 24 ]

2.  Primary:   Number of Participants Who Discontinued Treatment   [ Time Frame: Baseline up to Month 24 ]

3.  Primary:   Number of Participants by Reasons for Discontinuation of Treatment   [ Time Frame: Baseline up to Month 24 ]

4.  Secondary:   Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month   [ Time Frame: Baseline, Month 24 ]

5.  Secondary:   Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month   [ Time Frame: Baseline, Month 24 ]

6.  Secondary:   Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month   [ Time Frame: Baseline, Month 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00273858     History of Changes
Other Study ID Numbers: 0881A-101695, B1801106
Study First Received: January 4, 2006
Results First Received: June 30, 2011
Last Updated: September 8, 2011
Health Authority: Greece: National Organization of Medicines