Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.
NCT01421303
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | ||||
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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 | 80 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2014 |