Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. (AS@WORK)
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01421303
First received: August 19, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Drug: Enbrel |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Work Productivity in Active Ankylosing Spondylitis Patients Treated With Enbrel. |
Resource links provided by NLM:
Genetics Home Reference related topics:
ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| AS patients who are working and treated with Enbrel |
Drug: Enbrel
Enbrel
|
Detailed Description:
Purely descriptive
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
AS patients visiting the rheumatologist for which the decision has been taken to prescribe Enbrel
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01421303 History of Changes |
| Other Study ID Numbers: | 0881A3-4675, B1801053 |
| Study First Received: | August 19, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013