Extension Study Evaluating Etanercept in Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00410046
First received: December 8, 2006
Last updated: April 9, 2012
Last verified: April 2012
Results First Received: October 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ankylosing Spondylitis
Intervention: Drug: Enbrel (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
Patients were recruited in Europe from November 2006 to January 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients in 0881A3-402 (NCT00247962) were randomized to receive etanercept (ETN) or sulphasalazine (SSZ). After completion, they were eligible for enrollment into this extension study and all patients received ETN. Outcome measure analysis kept the 0881A3-402 assignment of ETN or SSZ. This enabled an analysis of changes from the original baseline.

Reporting Groups
  Description
Etanercept Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Participant Flow:   Overall Study
    Etanercept  
STARTED     84  
COMPLETED     79  
NOT COMPLETED     5  
Adverse Event                 3  
Withdrawal by Subject                 1  
Lost to Follow-up                 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.
No text entered.

Reporting Groups
  Description
Etanercept Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
  84  
Age  
[units: years]
Mean ± Standard Deviation
  42.70  ± 10.49  
Gender  
[units: patients]
 
Female     13  
Male     71  



  Outcome Measures
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1.  Primary:   Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment   [ Time Frame: 96 weeks ]

2.  Primary:   Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment   [ Time Frame: 96 weeks ]

3.  Secondary:   Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment   [ Time Frame: 48 weeks ]

4.  Secondary:   Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment   [ Time Frame: 48 weeks ]

5.  Secondary:   Number of Patients With Sick Leave During 48 Weeks Treatment   [ Time Frame: 48 weeks ]

6.  Secondary:   Number of Sick Days Per Patient During the 48 Weeks of Treatment   [ Time Frame: 48 weeks ]

7.  Secondary:   Change in Patient Global Assessment of Disease Activity From Baseline to Week 38   [ Time Frame: Baseline and 38 weeks ]

8.  Secondary:   Change in Total Back Pain Score From Baseline to Week 38   [ Time Frame: Baseline and 38 weeks ]

9.  Secondary:   Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38   [ Time Frame: Baseline and 38 weeks ]

10.  Secondary:   Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38   [ Time Frame: Baseline and 38 weeks ]

11.  Secondary:   Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38   [ Time Frame: Baseline and 38 weeks ]

12.  Secondary:   Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38   [ Time Frame: Baseline and 38 weeks ]

13.  Secondary:   Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38   [ Time Frame: Baseline and 38 weeks ]

14.  Secondary:   Change From Baseline Haywood Quality of Life Score From Baseline to Week 38   [ Time Frame: Baseline and 38 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00410046     History of Changes
Other Study ID Numbers: 0881A3-405
Study First Received: December 8, 2006
Results First Received: October 30, 2009
Last Updated: April 9, 2012
Health Authority: Denmark: National Board of Health