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

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NCT01421303

Last updated on October 10, 2019
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Study Location
Universitair Ziekenhuis Gent
Gent, , 9000 Belgium
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Contact
1-800-718-1021
[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.

NCT01421303
Pfizer
Completed
Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.

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Descriptive Information
Brief TitleWork Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.
Official TitleWork Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With Etanercept
Brief SummaryPatients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.
Detailed DescriptionPurely descriptive
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationAS patients visiting the rheumatologist for which the decision has been taken to prescribe Enbrel
ConditionAnkylosing Spondylitis
InterventionDrug: Enbrel
Enbrel
Study Groups/CohortsAS 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 StatusCompleted
Actual Enrollment
 (submitted: January 10, 2014)		80
Original Estimated Enrollment
 (submitted: August 19, 2011)		120
Actual Study Completion DateDecember 2013
Actual Primary Completion DateDecember 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesBelgium
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01421303
Other Study ID Numbers0881A3-4675
B1801053 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2014

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