Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-30 @ 12:39 AM
Study NCT ID:
NCT01421303
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2011-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'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.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', '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.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed (n=67)', 'categories': [{'measurements': [{'value': '30.18', 'spread': '40.64', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working (n=55)', 'categories': [{'measurements': [{'value': '49.09', 'spread': '22.87', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment (n=49)', 'categories': [{'measurements': [{'value': '53.06', 'spread': '25.67', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment (n=79)', 'categories': [{'measurements': [{'value': '63.29', 'spread': '21.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Percentage of impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'PRIMARY', 'title': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed (n=61)', 'categories': [{'measurements': [{'value': '6.23', 'spread': '22.55', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working (n=59)', 'categories': [{'measurements': [{'value': '27.97', 'spread': '22.42', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment (n=56)', 'categories': [{'measurements': [{'value': '28.07', 'spread': '23.45', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment (n=72)', 'categories': [{'measurements': [{'value': '31.81', 'spread': '24.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', '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.', 'unitOfMeasure': 'Percentage of impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'PRIMARY', 'title': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed (n=55)', 'categories': [{'measurements': [{'value': '5.52', 'spread': '22.91', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working (n=56)', 'categories': [{'measurements': [{'value': '25.18', 'spread': '22.40', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment (n=51)', 'categories': [{'measurements': [{'value': '23.97', 'spread': '21.75', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment (n=67)', 'categories': [{'measurements': [{'value': '29.55', 'spread': '26.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', '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.', 'unitOfMeasure': 'Percentage of impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'PRIMARY', 'title': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed (n=46)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '7.17', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working (n=45)', 'categories': [{'measurements': [{'value': '24.89', 'spread': '20.96', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment (n=44)', 'categories': [{'measurements': [{'value': '24.65', 'spread': '21.69', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment (n=55)', 'categories': [{'measurements': [{'value': '30.18', 'spread': '24.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', '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.', 'unitOfMeasure': 'Percentage of impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'PRIMARY', 'title': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed (n=41)', 'categories': [{'measurements': [{'value': '6.31', 'spread': '22.36', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working (n=41)', 'categories': [{'measurements': [{'value': '24.88', 'spread': '20.39', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment (n=38)', 'categories': [{'measurements': [{'value': '25.88', 'spread': '21.86', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment (n=56)', 'categories': [{'measurements': [{'value': '30.18', 'spread': '23.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', '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.', 'unitOfMeasure': 'Percentage of impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed (n=55)', 'categories': [{'measurements': [{'value': '-22.61', 'spread': '40.36', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Impairment While Working (n=44)', 'categories': [{'measurements': [{'value': '-22.05', 'spread': '24.55', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment (n=38)', 'categories': [{'measurements': [{'value': '-24.68', 'spread': '27.70', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment (n=72)', 'categories': [{'measurements': [{'value': '-31.53', 'spread': '26.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed (n=36)', 'categories': [{'measurements': [{'value': '-27.11', 'spread': '45.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Impairment While Working (n=27)', 'categories': [{'measurements': [{'value': '-29.63', 'spread': '19.71', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment (n=23)', 'categories': [{'measurements': [{'value': '-33.44', 'spread': '22.83', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment (n=56)', 'categories': [{'measurements': [{'value': '-33.75', 'spread': '25.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, Month 24', '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.', 'unitOfMeasure': 'Percentage of impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and BASDAI (n=66)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and BASDAI (n=55)', 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and BASDAI (n=49)', 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and BASDAI (n=78)', 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed and BASDAI (n=55)', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Impairment While Working and BASDAI(n=44)', 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment and BASDAI(n= 38)', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment and BASDAI (n=72)', 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed and BASDAI (n=36)', 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 24:Impairment While Working and BASDAI(n=27)', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Month 24:Overall work impairment and BASDAI(n= 23)', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment and BASDAI (n=56)', 'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and BASFI (n=67)', 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and BASFI (n=55)', 'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and BASFI (n= 49)', 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and BASFI (n=79)', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed and BASFI (n=55)', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Month 6:Impairment While Working and BASFI(n=44)', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment and BASFI(n=38)', 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment and BASFI (n=71)', 'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed and BASFI (n=36)', 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Month 24:Impairment While Working and BASFI(n=27)', 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment and BASFI(n=23)', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment and BASFI (n=56)', 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and BASMI (n=65)', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and BASMI (n=53)', 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and BASMI (n= 47)', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and BASMI (n=77)', 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.", 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed and BASMI (n=50)', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Impairment While Working and BASMI(n=41)', 'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment and BASMI (n=35)', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment and BASMI (n=66)', 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed and BASMI (n=33)', 'categories': [{'measurements': [{'value': '-0.088', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Impairment While Working and BASMI(n=24)', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment and BASMI(n=20)', 'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment and BASMI (n=53)', 'categories': [{'measurements': [{'value': '-0.070', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.", 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and BAS-G (n=67)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and BAS-G (n=55)', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and BAS-G (n=49)', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and BAS-G (n=79)', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.", 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed and BAS-G (n=55)', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Impairment While Working and BAS-G (n=44)', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment and BAS-G (n=38)', 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment and BAS-G (n=72)', 'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed and BAS-G (n=36)', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Impairment While Working and BAS-G(n=27)', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment and BAS-G (n=23)', 'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment and BAS-G (n=56)', 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.", 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and PCS (n=66)', 'categories': [{'measurements': [{'value': '-0.52', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and PCS (n=54)', 'categories': [{'measurements': [{'value': '-0.52', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and PCS (n=48)', 'categories': [{'measurements': [{'value': '-0.57', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and PCS (n=77)', 'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed and PCS (n=51)', 'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 6:Impairment While Working and PCS (n=41)', 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment and PCS(n=35)', 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment and PCS(n=66)', 'categories': [{'measurements': [{'value': '-0.57', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed and PCS(n=28)', 'categories': [{'measurements': [{'value': '-0.52', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Impairment While Working and PCS(n= 22)', 'categories': [{'measurements': [{'value': '-0.25', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment and PCS(n= 18)', 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment and PCS (n=45)', 'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and MCS (n=66)', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and MCS (n=54)', 'categories': [{'measurements': [{'value': '-0.38', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and MCS (n=48)', 'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and MCS (n=77)', 'categories': [{'measurements': [{'value': '-0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed and MCS (n=51)', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Impairment While Working and MCS(n=41)', 'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment and MCS(n=35)', 'categories': [{'measurements': [{'value': '-0.45', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment and MCS(n=66)', 'categories': [{'measurements': [{'value': '-0.29', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed and MCS(n=28)', 'categories': [{'measurements': [{'value': '0.038', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Impairment While Working and MCS(n= 22)', 'categories': [{'measurements': [{'value': '-0.006', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment and MCS(n= 18)', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment and MCS(n=45)', 'categories': [{'measurements': [{'value': '-0.39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and EQ-5D (n=66)', 'categories': [{'measurements': [{'value': '-0.17', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and EQ-5D (n=54)', 'categories': [{'measurements': [{'value': '-0.58', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and EQ-5D (n=48)', 'categories': [{'measurements': [{'value': '-0.59', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and EQ-5D (n=78)', 'categories': [{'measurements': [{'value': '-0.52', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed and EQ-5D (n=55)', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Impairment While Working and EQ-5D(n=44)', 'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment and EQ-5D(n=38)', 'categories': [{'measurements': [{'value': '-0.59', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment and EQ-5D(n=72)', 'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed and EQ-5D(n=34)', 'categories': [{'measurements': [{'value': '0.007', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Impairment While Working and EQ-5D(n=26)', 'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment and EQ-5D(n= 22)', 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment and EQ-5D(n=54)', 'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Work Time Missed and EQ-5D VAS (n=64)', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000'}]}]}, {'title': 'Impairment While Working and EQ-5D VAS (n=54)', 'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000'}]}]}, {'title': 'Overall work impairment and EQ-5D VAS (n=47)', 'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000'}]}]}, {'title': 'Activity impairment and EQ-5D VAS (n=75)', 'categories': [{'measurements': [{'value': '-0.59', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', '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.'}], 'classes': [{'title': 'Month 6: Work Time Missed, EQ-5D VAS (n=53)', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Impairment While Working, EQ-5D VAS(n=44)', 'categories': [{'measurements': [{'value': '-0.57', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Overall work impairment, EQ-5D VAS(n=38)', 'categories': [{'measurements': [{'value': '-0.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Activity impairment, EQ-5D VAS (n=70)', 'categories': [{'measurements': [{'value': '-0.54', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Work Time Missed, EQ-5D VAS (n=34)', 'categories': [{'measurements': [{'value': '0.009', 'groupId': 'OG000'}]}]}, {'title': 'Month 24:Impairment While Working, EQ-5D VAS(n=26)', 'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Overall work impairment, EQ-5D VAS(n=23)', 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: Activity impairment, EQ-5D VAS (n=53)', 'categories': [{'measurements': [{'value': '-0.52', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 24', '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.', 'unitOfMeasure': 'Correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': "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."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Non compliance with study procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel).'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2011-08-19', 'resultsFirstSubmitDate': '2014-12-05', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-05', 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline', 'timeFrame': 'Baseline', '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.'}, {'measure': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6', 'timeFrame': 'Month 6', '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.'}, {'measure': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12', 'timeFrame': 'Month 12', '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.'}, {'measure': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18', 'timeFrame': 'Month 18', '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.'}, {'measure': 'Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24', 'timeFrame': 'Month 24', '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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24', 'timeFrame': 'Baseline, Month 6, Month 24', '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.'}, {'measure': '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', 'timeFrame': 'Baseline', '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.'}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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.'}, {'measure': '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', 'timeFrame': 'Baseline', '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.'}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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.'}, {'measure': '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', 'timeFrame': 'Baseline', '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."}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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."}, {'measure': 'Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline', 'timeFrame': 'Baseline', '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."}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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."}, {'measure': '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', 'timeFrame': 'Baseline', '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.'}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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.'}, {'measure': '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', 'timeFrame': 'Baseline', '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.'}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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.'}, {'measure': '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', 'timeFrame': 'Baseline', '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.'}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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.'}, {'measure': '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', 'timeFrame': 'Baseline', '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.'}, {'measure': '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', 'timeFrame': 'Month 6, Month 24', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '29373701', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A3-4675&StudyName=Work%20Productivity%20in%20Active%20Ankylosing%20Spondylitis%20%28AS%29%20Patients%20Treated%20with%20Enbrel.%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.', 'detailedDescription': 'Purely descriptive'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'AS patients visiting the rheumatologist for which the decision has been taken to prescribe Enbrel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active AS patients (as judged by the treating MD) who are currently employed.\n* Patients who are scheduled by their rheumatologist to initiate treatment with Etanercept.\n\nExclusion Criteria:\n\n* Patients who initiated a procedure for eligibility of work disability/pension.\n* 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.'}, 'identificationModule': {'nctId': 'NCT01421303', 'acronym': 'AS@WORK', 'briefTitle': 'Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With Etanercept', 'orgStudyIdInfo': {'id': '0881A3-4675'}, 'secondaryIdInfos': [{'id': 'B1801053', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'AS patients who are working and treated with Enbrel', 'interventionNames': ['Drug: Enbrel']}], 'interventions': [{'name': 'Enbrel', 'type': 'DRUG', 'description': 'Enbrel', 'armGroupLabels': ['AS patients who are working and treated with Enbrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Gent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}