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
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
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 April 23, 2014