NCT01421303

Brief Summary

Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 12, 2014

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

4.2 years

First QC Date

August 19, 2011

Results QC Date

December 5, 2014

Last Update Submit

December 5, 2014

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (5)

  • Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline

    WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

    Baseline

  • Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6

    WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

    Month 6

  • Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12

    WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

    Month 12

  • Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18

    WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

    Month 18

  • Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24

    WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

    Month 24

Secondary Outcomes (17)

  • Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24

    Baseline, Month 6, Month 24

  • Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline

    Baseline

  • Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24

    Month 6, Month 24

  • Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline

    Baseline

  • Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24

    Month 6, Month 24

  • +12 more secondary outcomes

Study Arms (1)

AS patients who are working and treated with Enbrel

Drug: Enbrel

Interventions

EnbrelDRUG

Enbrel

AS patients who are working and treated with Enbrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AS patients visiting the rheumatologist for which the decision has been taken to prescribe Enbrel

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Gent

Ghent, Gent, 9000, Belgium

Location

Related Publications (1)

  • 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 AS@Work. Rheumatology (Oxford). 2018 May 1;57(5):791-797. doi: 10.1093/rheumatology/kex476.

    PMID: 29373701DERIVED

Related Links

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

October 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 12, 2014

Results First Posted

December 12, 2014

Record last verified: 2014-12

Locations

BE(1)