Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. (AS@WORK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01421303
First received: August 19, 2011
Last updated: December 5, 2014
Last verified: December 2014
Results First Received: December 5, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Ankylosing Spondylitis
Intervention: Drug: Enbrel

  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
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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 Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.

Participant Flow:   Overall Study
    Etanercept  
STARTED     80  
COMPLETED     58  
NOT COMPLETED     22  
Lost to Follow-up                 13  
Non compliance with study procedure                 1  
Unspecified                 7  
Withdrawal by Subject                 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.
Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel).

Reporting Groups
  Description
Etanercept Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
  80  
Age  
[units: years]
Mean ± Standard Deviation
  38.1  ± 9.1  
Gender  
[units: participants]
 
Female     40  
Male     40  



  Outcome Measures
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1.  Primary:   Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6   [ Time Frame: Month 6 ]

3.  Primary:   Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12   [ Time Frame: Month 12 ]

4.  Primary:   Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18   [ Time Frame: Month 18 ]

5.  Primary:   Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24   [ Time Frame: Month 24 ]

6.  Secondary:   Change From Baseline in Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24   [ Time Frame: Baseline, Month 6, Month 24 ]

7.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline   [ Time Frame: Baseline ]

8.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24   [ Time Frame: Month 6, Month 24 ]

9.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline   [ Time Frame: Baseline ]

10.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24   [ Time Frame: Month 6, Month 24 ]

11.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline   [ Time Frame: Baseline ]

12.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24   [ Time Frame: Month 6, Month 24 ]

13.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline   [ Time Frame: Baseline ]

14.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24   [ Time Frame: Month 6, Month 24 ]

15.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline   [ Time Frame: Baseline ]

16.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24   [ Time Frame: Month 6, Month 24 ]

17.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline   [ Time Frame: Baseline ]

18.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24   [ Time Frame: Month 6, Month 24 ]

19.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline   [ Time Frame: Baseline ]

20.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24   [ Time Frame: Month 6, Month 24 ]

21.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline   [ Time Frame: Baseline ]

22.  Secondary:   Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24   [ Time Frame: Month 6, Month 24 ]


  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: NCT01421303     History of Changes
Other Study ID Numbers: 0881A3-4675, B1801053
Study First Received: August 19, 2011
Results First Received: December 5, 2014
Last Updated: December 5, 2014
Health Authority: Belgium: Institutional Review Board