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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01421303
First received: August 19, 2011
Last updated: January 10, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 80
Study Start Date: October 2009
Study Completion Date: December 2013
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421303

Locations
Belgium
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  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: January 10, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014