Universitair Ziekenhuis Gent
Ghent, Gent, 9000, Belgium
NCT Number: NCT01421303
Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.
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Notify Me18 year and older
All sexes
Observational
Ghent, Gent, 9000, Belgium
Purely descriptive
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enbrel
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 6, 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 (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
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: Month 6, Month 24
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: Baseline
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: Month 6, Month 24
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: Baseline
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: Month 6, Month 24
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: Baseline
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: Month 6, Month 24
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: Baseline
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: Month 6, Month 24
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: Baseline
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: Month 6, Month 24
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: Baseline
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: Month 6, Month 24
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: Baseline
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: Month 6, Month 24
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.
Pfizer
Industry
Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With Etanercept
Acronym: AS@WORK
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