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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: January 10, 2014
Last verified: January 2014

August 19, 2011
January 10, 2014
October 2009
December 2013   (final data collection date for primary outcome measure)
  • Work Productivity and Activity Impairment (WPAI) % work time missed due to AS (absenteeism) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • WPAI % impairment while working due to AS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • WPAI % activity impairment due to AS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • WPAI overall work impairment score due to AS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • WPAI % work time missed due to AS (absenteeism) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • WPAI % impairment while working due to AS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • WPAI % activity impairment due to AS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • WPAI overall work impairment score due to AS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01421303 on ClinicalTrials.gov Archive Site
Changes in summary WPAI-SA score (3 domains) contrasting scores at 6 months vs baseline and at 24 months vs baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To compare changes in summary WPAI-SA score (3 domains) contrasting scores at 6 months vs baseline and at 24 months vs baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.
Work Productivity in Active Ankylosing Spondylitis Patients Treated With Enbrel.

Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.

Purely descriptive

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

AS patients visiting the rheumatologist for which the decision has been taken to prescribe Enbrel

Ankylosing Spondylitis
Drug: Enbrel
Enbrel
AS patients who are working and treated with Enbrel
Intervention: Drug: Enbrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active AS patients (as judged by the treating MD) who are currently employed.
  • Patients who are scheduled by their rheumatologist to initiate treatment with Etanercept.

Exclusion Criteria:

  • Patients who initiated a procedure for eligibility of work disability/pension.
  • Patients with previous use of TNF-alpha inhibitors either in commercial use, or in a study for the treatment of AS or a related spondylarthropathy condition.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01421303
0881A3-4675, B1801053
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP