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Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain (Loadet)

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00873730
First received: April 1, 2009
Last updated: April 23, 2010
Last verified: April 2010
History of Changes
Results First Received: June 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Ankylosing Spondylitis
Interventions: Drug: etanercept
Drug: etanercept/placebo

  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 Spain from December 2006 to February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened up to 6 weeks.

Reporting Groups
  Description
Etanercept BIW etanercept 50 mg twice a week (BIW) for 12 weeks
Etanercept QW etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks

Participant Flow:   Overall Study
    Etanercept BIW     Etanercept QW  
STARTED     54     54  
COMPLETED     48     49  
NOT COMPLETED     6     5  
Protocol Deviation                 5                 2  
Adverse Event                 0                 2  
Withdrawal by Subject                 0                 1  
Sponsor decision                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Etanercept BIW etanercept 50 mg twice a week (BIW) for 12 weeks
Etanercept QW etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Etanercept BIW     Etanercept QW     Total  
Number of Participants  
[units: participants]
 		  54     54     108  
Age  
[units: years]
Mean ± Standard Deviation 		  40.22  ± 10.36     42.63  ± 10.66     41.43  ± 10.53  
Gender  
[units: participants]
 		     
Female     11     11     22  
Male     43     43     86  



  Outcome Measures
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1.  Primary:   Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.   [ Time Frame: 12 weeks ]
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2.  Secondary:   Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.   [ Time Frame: 12 weeks ]
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3.  Secondary:   Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.   [ Time Frame: 12 weeks ]
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4.  Secondary:   Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.   [ Time Frame: 12 weeks ]
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5.  Secondary:   Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.   [ Time Frame: 12 weeks ]
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6.  Secondary:   Number of Patients Achieving Partial Remission.   [ Time Frame: 12 weeks ]
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7.  Secondary:   Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
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8.  Secondary:   Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
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9.  Secondary:   Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
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10.  Secondary:   Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
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12.  Secondary:   Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
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13.  Secondary:   Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire   [ Time Frame: 12 weeks ]
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14.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
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15.  Secondary:   Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms   [ Time Frame: 12 weeks ]
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16.  Secondary:   Change in C-reactive Protein (CRP) From Baseline to Week 12.   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 16


  Serious Adverse Events
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  Other Adverse Events
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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.


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 by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00873730     History of Changes
Other Study ID Numbers: 0881A3-406
Study First Received: April 1, 2009
Results First Received: June 30, 2009
Last Updated: April 23, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica