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

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NCT01421303

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Study Location
Universitair Ziekenhuis Gent
Gent, , 9000, Belgium
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Contact
1-800-718-1021
ClinicalTrials.gov_Inqui[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.
Official Title Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With Etanercept
Brief Summary Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.
Detailed Description Purely descriptive
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population AS patients visiting the rheumatologist for which the decision has been taken to prescribe Enbrel
Condition Ankylosing Spondylitis
Intervention Drug: Enbrel
Enbrel
Study Groups/Cohorts AS patients who are working and treated with Enbrel
Intervention: Drug: Enbrel
Publications * Boonen A, Boone C, Albert A, Mielants H. Contextual factors influence work outcomes in employed patients with ankylosing spondylitis starting etanercept: 2-year results from [email protected] Rheumatology (Oxford). 2018 May 1;57(5):791-797. doi: 10.1093/rheumatology/kex476.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 10, 2014)		80
Original Estimated Enrollment
 (submitted: August 19, 2011)		120
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01421303
Other Study ID Numbers 0881A3-4675
B1801053 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2014