Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.
NCT01421303
Last updated date
ABOUT THIS STUDY
Patients with Ankylosing spondylitis more frequently discontinue work. This study measures
the impact of Enbrel on work participation.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical 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.
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 | 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 | |||