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

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ClinicalTrials.gov Identifier: NCT01421303
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Ankylosing Spondylitis
Intervention Drug: Enbrel
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept
Hide Arm/Group Description Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Period Title: Overall Study
Started 80
Completed 58
Not Completed 22
Reason Not Completed
Lost to Follow-up             13
Non compliance with study procedure             1
Other             7
Withdrawal by Subject             1
Arm/Group Title Etanercept
Hide Arm/Group Description Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
38.1  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
40
  50.0%
Male
40
  50.0%
1.Primary Outcome
Title Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline
Hide Description 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.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given sub-scale items at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: Percentage of impairment
Work Time Missed (n=67) 30.18  (40.64)
Impairment While Working (n=55) 49.09  (22.87)
Overall work impairment (n=49) 53.06  (25.67)
Activity impairment (n=79) 63.29  (21.47)
2.Primary Outcome
Title Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6
Hide Description 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.
Time Frame Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Follow-up analysis set (FAS) consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 6.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: Percentage of impairment
Work Time Missed (n=61) 6.23  (22.55)
Impairment While Working (n=59) 27.97  (22.42)
Overall work impairment (n=56) 28.07  (23.45)
Activity impairment (n=72) 31.81  (24.57)
3.Primary Outcome
Title Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12
Hide Description 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.
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 12.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: Percentage of impairment
Work Time Missed (n=55) 5.52  (22.91)
Impairment While Working (n=56) 25.18  (22.40)
Overall work impairment (n=51) 23.97  (21.75)
Activity impairment (n=67) 29.55  (26.02)
4.Primary Outcome
Title Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18
Hide Description 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.
Time Frame Month 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 18.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: Percentage of impairment
Work Time Missed (n=46) 1.06  (7.17)
Impairment While Working (n=45) 24.89  (20.96)
Overall work impairment (n=44) 24.65  (21.69)
Activity impairment (n=55) 30.18  (24.30)
5.Primary Outcome
Title Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24
Hide Description 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.
Time Frame Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 24.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: Percentage of impairment
Work Time Missed (n=41) 6.31  (22.36)
Impairment While Working (n=41) 24.88  (20.39)
Overall work impairment (n=38) 25.88  (21.86)
Activity impairment (n=56) 30.18  (23.55)
6.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24
Hide Description 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 (AS) for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) 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.
Time Frame Baseline, Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: Percentage of impairment
Month 6: Work Time Missed (n=55) -22.61  (40.36)
Month 6: Impairment While Working (n=44) -22.05  (24.55)
Month 6: Overall work impairment (n=38) -24.68  (27.70)
Month 6: Activity impairment (n=72) -31.53  (26.41)
Month 24: Work Time Missed (n=36) -27.11  (45.41)
Month 24: Impairment While Working (n=27) -29.63  (19.71)
Month 24: Overall work impairment (n=23) -33.44  (22.83)
Month 24: Activity impairment (n=56) -33.75  (25.05)
7.Secondary Outcome
Title 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
Hide Description WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), 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. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between WPAI-AS and BASDAI score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and BASDAI (n=66) 0.21
Impairment While Working and BASDAI (n=55) 0.60
Overall work impairment and BASDAI (n=49) 0.62
Activity impairment and BASDAI (n=78) 0.62
8.Secondary Outcome
Title 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
Hide Description WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), 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. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between change from baseline in WPAI-AS and BASDAI score at Month 6 and 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed and BASDAI (n=55) 0.23
Month 6: Impairment While Working and BASDAI(n=44) 0.62
Month 6: Overall work impairment and BASDAI(n= 38) 0.56
Month 6: Activity impairment and BASDAI (n=72) 0.55
Month 24: Work Time Missed and BASDAI (n=36) 0.41
Month 24:Impairment While Working and BASDAI(n=27) 0.42
Month 24:Overall work impairment and BASDAI(n= 23) 0.40
Month 24: Activity impairment and BASDAI (n=56) 0.63
9.Secondary Outcome
Title 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
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between WPAI-AS and BASFI score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and BASFI (n=67) 0.29
Impairment While Working and BASFI (n=55) 0.59
Overall work impairment and BASFI (n= 49) 0.58
Activity impairment and BASFI (n=79) 0.54
10.Secondary Outcome
Title 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
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between change from baseline in WPAI-AS and BASFI score at Month 6, 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at visit 1 (baseline), started the treatment with etanercept and had at least one visit during follow-up. Here 'n' signifies those participants who were evaluable at specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed and BASFI (n=55) 0.36
Month 6:Impairment While Working and BASFI(n=44) 0.56
Month 6: Overall work impairment and BASFI(n=38) 0.62
Month 6: Activity impairment and BASFI (n=71) 0.62
Month 24: Work Time Missed and BASFI (n=36) 0.37
Month 24:Impairment While Working and BASFI(n=27) 0.47
Month 24: Overall work impairment and BASFI(n=23) 0.43
Month 24: Activity impairment and BASFI (n=56) 0.57
11.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between WPAI-AS and BASMI score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and BASMI (n=65) 0.06
Impairment While Working and BASMI (n=53) 0.30
Overall work impairment and BASMI (n= 47) 0.23
Activity impairment and BASMI (n=77) 0.08
12.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between change from baseline in WPAI-AS and BASMI score at Month 6, 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed and BASMI (n=50) 0.17
Month 6: Impairment While Working and BASMI(n=41) 0.26
Month 6: Overall work impairment and BASMI (n=35) 0.12
Month 6: Activity impairment and BASMI (n=66) 0.31
Month 24: Work Time Missed and BASMI (n=33) -0.088
Month 24: Impairment While Working and BASMI(n=24) 0.34
Month 24: Overall work impairment and BASMI(n=20) 0.39
Month 24: Activity impairment and BASMI (n=53) -0.070
13.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between WPAI-AS and BAS-G score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and BAS-G (n=67) 0.21
Impairment While Working and BAS-G (n=55) 0.48
Overall work impairment and BAS-G (n=49) 0.48
Activity impairment and BAS-G (n=79) 0.61
14.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between change from baseline in WPAI-AS and BAS-G score at Month 6, 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed and BAS-G (n=55) 0.34
Month 6: Impairment While Working and BAS-G (n=44) 0.56
Month 6: Overall work impairment and BAS-G (n=38) 0.55
Month 6: Activity impairment and BAS-G (n=72) 0.64
Month 24: Work Time Missed and BAS-G (n=36) 0.25
Month 24: Impairment While Working and BAS-G(n=27) 0.28
Month 24: Overall work impairment and BAS-G (n=23) 0.26
Month 24: Activity impairment and BAS-G (n=56) 0.60
15.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline
Hide Description WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and mental component summary (MCS).Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and PCS score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and PCS (n=66) -0.52
Impairment While Working and PCS (n=54) -0.52
Overall work impairment and PCS (n=48) -0.57
Activity impairment and PCS (n=77) -0.43
16.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24
Hide Description WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity),activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100),higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and PCS score at Month 6, 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed and PCS (n=51) -0.41
Month 6:Impairment While Working and PCS (n=41) -0.36
Month 6: Overall work impairment and PCS(n=35) -0.36
Month 6: Activity impairment and PCS(n=66) -0.57
Month 24: Work Time Missed and PCS(n=28) -0.52
Month 24: Impairment While Working and PCS(n= 22) -0.25
Month 24: Overall work impairment and PCS(n= 18) -0.36
Month 24: Activity impairment and PCS (n=45) -0.60
17.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline
Hide Description WPAI-AS: 6-item questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). Sub-scores transformed to impairment percentages (range 0 to 100), higher numbers=greater impairment,less productivity. SF-36:standardized survey evaluating 8 aspects of functional health, well being (physical, social functioning; physical, emotional role limitations; bodily pain; general health; vitality; mental health). 8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50, standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and MCS score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and MCS (n=66) -0.06
Impairment While Working and MCS (n=54) -0.38
Overall work impairment and MCS (n=48) -0.41
Activity impairment and MCS (n=77) -0.51
18.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24
Hide Description WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10(norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and MCS score at Month 6, 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed and MCS (n=51) -0.19
Month 6: Impairment While Working and MCS(n=41) -0.33
Month 6: Overall work impairment and MCS(n=35) -0.45
Month 6: Activity impairment and MCS(n=66) -0.29
Month 24: Work Time Missed and MCS(n=28) 0.038
Month 24: Impairment While Working and MCS(n= 22) -0.006
Month 24: Overall work impairment and MCS(n= 18) 0.36
Month 24: Activity impairment and MCS(n=45) -0.39
19.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between WPAI-AS and EQ-5D total score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and EQ-5D (n=66) -0.17
Impairment While Working and EQ-5D (n=54) -0.58
Overall work impairment and EQ-5D (n=48) -0.59
Activity impairment and EQ-5D (n=78) -0.52
20.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between change from baseline in WPAI-AS and EQ-5D total score at Month 6, 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed and EQ-5D (n=55) -0.19
Month 6: Impairment While Working and EQ-5D(n=44) -0.60
Month 6: Overall work impairment and EQ-5D(n=38) -0.59
Month 6: Activity impairment and EQ-5D(n=72) -0.33
Month 24: Work Time Missed and EQ-5D(n=34) 0.007
Month 24: Impairment While Working and EQ-5D(n=26) -0.33
Month 24: Overall work impairment and EQ-5D(n= 22) -0.20
Month 24: Activity impairment and EQ-5D(n=54) -0.43
21.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between WPAI-AS and EQ-5D VAS score at baseline was reported.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Correlation coefficient
Work Time Missed and EQ-5D VAS (n=64) -0.06
Impairment While Working and EQ-5D VAS (n=54) -0.42
Overall work impairment and EQ-5D VAS (n=47) -0.47
Activity impairment and EQ-5D VAS (n=75) -0.59
22.Secondary Outcome
Title Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24
Hide Description WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between change from baseline in WPAI-AS and EQ-5D VAS score at Month 6, 24 was reported.
Time Frame Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Correlation coefficient
Month 6: Work Time Missed, EQ-5D VAS (n=53) -0.15
Month 6: Impairment While Working, EQ-5D VAS(n=44) -0.57
Month 6: Overall work impairment, EQ-5D VAS(n=38) -0.62
Month 6: Activity impairment, EQ-5D VAS (n=70) -0.54
Month 24: Work Time Missed, EQ-5D VAS (n=34) 0.009
Month 24:Impairment While Working, EQ-5D VAS(n=26) -0.32
Month 24: Overall work impairment, EQ-5D VAS(n=23) -0.36
Month 24: Activity impairment, EQ-5D VAS (n=53) -0.52
Time Frame [Not Specified]
Adverse Event Reporting Description Only serious adverse events (SAEs) were planned to be collected. Other AEs were not collected as per planned analysis for this non-interventional study.
 
Arm/Group Title Etanercept
Hide Arm/Group Description Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
All-Cause Mortality
Etanercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept
Affected / at Risk (%)
Total   0/80 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01421303     History of Changes
Other Study ID Numbers: 0881A3-4675
B1801053 ( Other Identifier: Alias Study Number )
First Submitted: August 19, 2011
First Posted: August 22, 2011
Results First Submitted: December 5, 2014
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014