Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-06 @ 9:42 PM
Study NCT ID:
NCT01845818
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2013-05-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], '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'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 23 months plus 70 days. The average adalimumab treatment duration was 14.9 months (standard deviation: 5.6).', 'description': 'Adverse events were analyzed for all participants as one group, per protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 0, 'seriousNumAtRisk': 173, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis and psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.15', 'spread': '35.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 18', 'description': 'The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\\* \\[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.', 'unitOfMeasure': 'percentage of TWPI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.47', 'spread': '34.88', 'groupId': 'OG000'}, {'value': '-26.11', 'spread': '37.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 18', 'description': 'The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\\* \\[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.', 'unitOfMeasure': 'percentage of TWPI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Employed at Each Assessed Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Baseline : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}]}, {'title': 'Baseline : All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}]}, {'title': 'Month 3 : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Month 3 : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}]}, {'title': 'Month 3 : All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 : All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 : All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Month 18 : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Month 18 : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}, {'title': 'Month 18 : All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation : All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'As assessed by the WPAI questionnaire, a questionnaire used to evaluate lost work productivity due to disease (yes=employed; no=not employed). Last observation is the last observation after baseline at which any of the questionnaire items was completed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.29', 'spread': '40.09', 'groupId': 'OG000'}, {'value': '12.27', 'spread': '27.76', 'groupId': 'OG001'}, {'value': '20.39', 'spread': '36.86', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.24', 'spread': '29.53', 'groupId': 'OG000'}, {'value': '5.39', 'spread': '19.56', 'groupId': 'OG001'}, {'value': '8.57', 'spread': '26.53', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.79', 'spread': '21.45', 'groupId': 'OG000'}, {'value': '5.82', 'spread': '19.58', 'groupId': 'OG001'}, {'value': '6.45', 'spread': '20.72', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.90', 'spread': '21.00', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '10.66', 'groupId': 'OG001'}, {'value': '4.94', 'spread': '18.83', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.19', 'spread': '31.34', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '10.00', 'groupId': 'OG001'}, {'value': '8.97', 'spread': '26.85', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.94', 'spread': '31.71', 'groupId': 'OG000'}, {'value': '4.41', 'spread': '18.94', 'groupId': 'OG001'}, {'value': '10.31', 'spread': '28.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'Absenteeism, presented as the mean percentage of work time missed due to disease (as reported on the WPAI), and calculated as: 100\\*number of hours of work missed due to disease / (number of hours of work missed due to disease + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.', 'unitOfMeasure': 'percentage of work time missed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.25', 'spread': '22.75', 'groupId': 'OG000'}, {'value': '57.25', 'spread': '26.01', 'groupId': 'OG001'}, {'value': '60.68', 'spread': '23.86', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.59', 'spread': '28.68', 'groupId': 'OG000'}, {'value': '32.22', 'spread': '27.21', 'groupId': 'OG001'}, {'value': '37.27', 'spread': '28.34', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.61', 'spread': '26.05', 'groupId': 'OG000'}, {'value': '33.72', 'spread': '27.95', 'groupId': 'OG001'}, {'value': '32.31', 'spread': '26.60', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.33', 'spread': '26.22', 'groupId': 'OG000'}, {'value': '30.00', 'spread': '29.50', 'groupId': 'OG001'}, {'value': '30.91', 'spread': '27.17', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.59', 'spread': '27.89', 'groupId': 'OG000'}, {'value': '25.13', 'spread': '28.46', 'groupId': 'OG001'}, {'value': '27.36', 'spread': '28.01', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.17', 'spread': '28.75', 'groupId': 'OG000'}, {'value': '32.73', 'spread': '29.22', 'groupId': 'OG001'}, {'value': '33.68', 'spread': '28.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'Activity impairment due to disease (the extent to which disease affected the ability to perform usual daily activities, as reported on the WPAI) is presented as the mean percentage of activity impairment, calculated as 100\\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.', 'unitOfMeasure': 'percentage activity impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.45', 'spread': '25.91', 'groupId': 'OG000'}, {'value': '46.18', 'spread': '30.35', 'groupId': 'OG001'}, {'value': '52.30', 'spread': '27.70', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.44', 'spread': '24.48', 'groupId': 'OG000'}, {'value': '26.18', 'spread': '27.53', 'groupId': 'OG001'}, {'value': '25.05', 'spread': '25.46', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.67', 'spread': '19.30', 'groupId': 'OG000'}, {'value': '28.75', 'spread': '29.04', 'groupId': 'OG001'}, {'value': '24.78', 'spread': '23.18', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.17', 'spread': '24.11', 'groupId': 'OG000'}, {'value': '15.65', 'spread': '20.41', 'groupId': 'OG001'}, {'value': '22.53', 'spread': '23.42', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '27.97', 'groupId': 'OG000'}, {'value': '19.29', 'spread': '25.81', 'groupId': 'OG001'}, {'value': '23.00', 'spread': '27.21', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.93', 'spread': '29.25', 'groupId': 'OG000'}, {'value': '26.39', 'spread': '28.40', 'groupId': 'OG001'}, {'value': '28.11', 'spread': '28.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'As measured by the WPAI-Specific Health Problem questionnaire. Presenteeism (the extent to which disease decreased productivity, as reported on the WPAI) is presented as the mean percentage of impairment while working due to disease, and calculated as: 100\\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.', 'unitOfMeasure': 'percentage impairment while working', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The HAQ-DI is a self-reported assessment of how the participant's disease affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores: dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. Scores range from 0 to 3, with a lower score demonstrating less disability. Last observation is the last observation after baseline at which any of the questionnaire items was completed.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.85', 'spread': '7.25', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.11', 'spread': '5.72', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.29', 'spread': '6.93', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.30', 'spread': '4.81', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.08', 'spread': '4.84', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.24', 'spread': '6.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0); responses are summed. The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Last observation is the last observation after baseline at which any of the questionnaire items was completed.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Last observation is the last observation after baseline at which any of the questionnaire items was completed.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.37', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.99', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.99', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.05', 'spread': '1.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The DAS-28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \\[low activity\\] to 10 \\[high activity\\]) are included in the DAS-28 score. Scores on the DAS-28 range from 0 to 10. A DAS-28 score \\> 5.1 indicates high disease activity, a DAS-28 score \\< 3.2 indicates low disease activity, and a DAS-28 score \\< 2.6 indicates clinical remission. Last observation is the last observation after baseline at which any of the questionnaire items was completed.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline: 0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: < 3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: 3% to 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: 11% to 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: > 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: 0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: < 3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: 3% to 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: 11% to 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: > 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: 0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: < 3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: 3% to 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: 11% to 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: > 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: 0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: < 3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: 3% to 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: 11% to 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: > 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 18: 0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 18: < 3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 18: 3% to 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 18: 11% to 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 18: > 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation: 0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation: < 3%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation: 3% to 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation: 11% to 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation: > 20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'Percentage of BSA affected by psoriatic arthritis was assessed by clinical evaluation. Last observation is the last observation after baseline at which any of the questionnaire items was completed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a BSA assessment at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.85', 'spread': '1.32', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.97', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.18', 'spread': '2.01', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.27', 'spread': '2.37', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.21', 'groupId': 'OG000'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.76', 'spread': '2.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The BASDAI is used for measuring and evaluating disease activity in ankylosing spondylitis. This index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0 to 10 (0 being no problem and 10 being the worst problem). Last observation is the last observation after baseline at which any of the questionnaire items was completed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.14', 'spread': '14.74', 'groupId': 'OG000'}, {'value': '12.77', 'spread': '12.05', 'groupId': 'OG001'}, {'value': '14.25', 'spread': '13.80', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.23', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '5.17', 'groupId': 'OG001'}, {'value': '7.41', 'spread': '7.21', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.65', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '10.83', 'spread': '13.62', 'groupId': 'OG001'}, {'value': '8.78', 'spread': '10.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.38', 'spread': '8.54', 'groupId': 'OG000'}, {'value': '10.03', 'spread': '11.86', 'groupId': 'OG001'}, {'value': '8.47', 'spread': '10.05', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.63', 'spread': '6.84', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '5.98', 'groupId': 'OG001'}, {'value': '7.46', 'spread': '6.50', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.19', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '10.84', 'spread': '12.49', 'groupId': 'OG001'}, {'value': '9.14', 'spread': '9.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. Last observation is the last observation after baseline at which an assessment was completed.', 'unitOfMeasure': 'mm/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.'}, {'type': 'SECONDARY', 'title': 'Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.36', 'spread': '7.16', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '3.06', 'groupId': 'OG001'}, {'value': '2.08', 'spread': '6.15', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '1.23', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '0.69', 'spread': '1.54', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '1.66', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '1.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. Last observation is the last observation after baseline at which an assessment was completed.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67.14', 'spread': '16.03', 'groupId': 'OG000'}, {'value': '59.35', 'spread': '15.65', 'groupId': 'OG001'}, {'value': '64.58', 'spread': '16.28', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.92', 'spread': '20.51', 'groupId': 'OG000'}, {'value': '21.19', 'spread': '17.23', 'groupId': 'OG001'}, {'value': '23.62', 'spread': '19.45', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.40', 'spread': '17.57', 'groupId': 'OG000'}, {'value': '19.34', 'spread': '16.08', 'groupId': 'OG001'}, {'value': '18.73', 'spread': '17.01', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.13', 'spread': '17.76', 'groupId': 'OG000'}, {'value': '17.12', 'spread': '15.54', 'groupId': 'OG001'}, {'value': '17.79', 'spread': '17.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.39', 'spread': '18.03', 'groupId': 'OG000'}, {'value': '15.07', 'spread': '17.91', 'groupId': 'OG001'}, {'value': '16.57', 'spread': '17.95', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.70', 'spread': '21.00', 'groupId': 'OG000'}, {'value': '18.31', 'spread': '18.36', 'groupId': 'OG001'}, {'value': '20.55', 'spread': '20.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The VAS score assessed by physicians was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.'}, {'type': 'SECONDARY', 'title': "Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67.53', 'spread': '20.14', 'groupId': 'OG000'}, {'value': '60.89', 'spread': '19.91', 'groupId': 'OG001'}, {'value': '65.36', 'spread': '20.25', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.31', 'spread': '26.97', 'groupId': 'OG000'}, {'value': '30.42', 'spread': '25.58', 'groupId': 'OG001'}, {'value': '34.35', 'spread': '26.58', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.80', 'spread': '23.58', 'groupId': 'OG000'}, {'value': '34.46', 'spread': '28.63', 'groupId': 'OG001'}, {'value': '28.73', 'spread': '25.63', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.89', 'spread': '26.48', 'groupId': 'OG000'}, {'value': '29.00', 'spread': '27.39', 'groupId': 'OG001'}, {'value': '28.93', 'spread': '26.66', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.86', 'spread': '24.30', 'groupId': 'OG000'}, {'value': '24.55', 'spread': '25.30', 'groupId': 'OG001'}, {'value': '24.75', 'spread': '24.55', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.31', 'spread': '26.95', 'groupId': 'OG000'}, {'value': '32.64', 'spread': '28.18', 'groupId': 'OG001'}, {'value': '31.75', 'spread': '27.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The VAS score assessed by participants was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.'}, {'type': 'SECONDARY', 'title': "Participant's Global Assessment of Pain VAS Scores Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis in whom adalimumab treatment was initiated.'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis in whom adalimumab treatment was initiated.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with ankylosing spondylitis or psoriatic arthritis in whom adalimumab treatment was initiated.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.17', 'spread': '18.59', 'groupId': 'OG000'}, {'value': '64.24', 'spread': '19.02', 'groupId': 'OG001'}, {'value': '68.23', 'spread': '18.88', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.91', 'spread': '27.63', 'groupId': 'OG000'}, {'value': '29.60', 'spread': '25.97', 'groupId': 'OG001'}, {'value': '35.14', 'spread': '27.28', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.73', 'spread': '24.49', 'groupId': 'OG000'}, {'value': '34.93', 'spread': '30.51', 'groupId': 'OG001'}, {'value': '30.17', 'spread': '26.78', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.55', 'spread': '26.80', 'groupId': 'OG000'}, {'value': '30.79', 'spread': '29.73', 'groupId': 'OG001'}, {'value': '29.94', 'spread': '27.64', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.41', 'spread': '25.84', 'groupId': 'OG000'}, {'value': '25.68', 'spread': '27.69', 'groupId': 'OG001'}, {'value': '26.78', 'spread': '26.41', 'groupId': 'OG002'}]}]}, {'title': 'Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.35', 'spread': '27.92', 'groupId': 'OG000'}, {'value': '33.93', 'spread': '30.69', 'groupId': 'OG001'}, {'value': '33.55', 'spread': '28.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The VAS score assessed by participants was used to determine the pain due to ankylosing spondylitis and psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis and in whom adalimumab treatment is initiated.'}, {'id': 'FG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis and in whom adalimumab treatment is initiated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Administrative Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Did Not Receive Any Dose of Adalimumab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No Follow-Up Data Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ankylosing Spondylitis', 'description': 'Participants with ankylosing spondylitis and in whom adalimumab treatment was initiated.'}, {'id': 'BG001', 'title': 'Psoriatic Arthritis', 'description': 'Participants with psoriatic arthritis and in whom adalimumab treatment was initiated.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.74', 'spread': '9.55', 'groupId': 'BG000'}, {'value': '43.32', 'spread': '8.39', 'groupId': 'BG001'}, {'value': '39.54', 'spread': '9.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}, {'title': 'Other (Not Specified)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Work Productivity Impairment (TWPI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.09', 'spread': '27.47', 'groupId': 'BG000'}, {'value': '47.54', 'spread': '31.86', 'groupId': 'BG001'}, {'value': '53.84', 'spread': '29.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean percentage of TWPI due to disease (based on the Work Productivity and Activity Impairment \\[WPAI\\] questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\\* \\[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.', 'unitOfMeasure': 'percentage of TWPI', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with a questionnaire completed at baseline are included.'}], 'populationDescription': 'Participants who not receive any dose of adalimumab and those who had no follow-up data available (see Participant Flow) are not included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-12-06', 'size': 716007, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-06T11:24', 'hasProtocol': True}, {'date': '2016-10-04', 'size': 359103, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-06T11:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2013-05-01', 'resultsFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-08', 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)', 'timeFrame': 'Baseline, Month 18', 'description': 'The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\\* \\[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)', 'timeFrame': 'Baseline, Month 18', 'description': 'The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)\\* \\[number of hours worked / (number of hours of work missed due to disease + number of hours worked)\\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at Month 18.'}, {'measure': 'Number of Participants Employed at Each Assessed Visit', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'As assessed by the WPAI questionnaire, a questionnaire used to evaluate lost work productivity due to disease (yes=employed; no=not employed). Last observation is the last observation after baseline at which any of the questionnaire items was completed.'}, {'measure': 'Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'Absenteeism, presented as the mean percentage of work time missed due to disease (as reported on the WPAI), and calculated as: 100\\*number of hours of work missed due to disease / (number of hours of work missed due to disease + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.'}, {'measure': 'Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'Activity impairment due to disease (the extent to which disease affected the ability to perform usual daily activities, as reported on the WPAI) is presented as the mean percentage of activity impairment, calculated as 100\\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.'}, {'measure': 'Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'As measured by the WPAI-Specific Health Problem questionnaire. Presenteeism (the extent to which disease decreased productivity, as reported on the WPAI) is presented as the mean percentage of impairment while working due to disease, and calculated as: 100\\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.'}, {'measure': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The HAQ-DI is a self-reported assessment of how the participant's disease affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores: dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. Scores range from 0 to 3, with a lower score demonstrating less disability. Last observation is the last observation after baseline at which any of the questionnaire items was completed."}, {'measure': 'Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0); responses are summed. The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Last observation is the last observation after baseline at which any of the questionnaire items was completed."}, {'measure': 'Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Last observation is the last observation after baseline at which any of the questionnaire items was completed."}, {'measure': 'Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': "The DAS-28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \\[low activity\\] to 10 \\[high activity\\]) are included in the DAS-28 score. Scores on the DAS-28 range from 0 to 10. A DAS-28 score \\> 5.1 indicates high disease activity, a DAS-28 score \\< 3.2 indicates low disease activity, and a DAS-28 score \\< 2.6 indicates clinical remission. Last observation is the last observation after baseline at which any of the questionnaire items was completed."}, {'measure': 'Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'Percentage of BSA affected by psoriatic arthritis was assessed by clinical evaluation. Last observation is the last observation after baseline at which any of the questionnaire items was completed.'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The BASDAI is used for measuring and evaluating disease activity in ankylosing spondylitis. This index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0 to 10 (0 being no problem and 10 being the worst problem). Last observation is the last observation after baseline at which any of the questionnaire items was completed.'}, {'measure': 'Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. Last observation is the last observation after baseline at which an assessment was completed.'}, {'measure': 'Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time', 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. Last observation is the last observation after baseline at which an assessment was completed.'}, {'measure': "Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time", 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The VAS score assessed by physicians was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).'}, {'measure': "Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time", 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The VAS score assessed by participants was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).'}, {'measure': "Participant's Global Assessment of Pain VAS Scores Over Time", 'timeFrame': 'Baseline, Months 3, 6, 12, 18', 'description': 'The VAS score assessed by participants was used to determine the pain due to ankylosing spondylitis and psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['work productivity', 'multicenter study'], 'conditions': ['Ankylosing Spondylitis', 'Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This observational study will document to what extent in daily clinical practice the work productivity is affected before and after the start of adalimumab treatment.\n\nChanges in the employment status and work productivity of participants with AS and PsA before and after the start of adalimumab will be noted. The relationship between employment status, work productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA might be diseases with a strong impact on the daily life of the participant, an evaluation will be performed to the effect of the disease on quality of life and work productivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with AS and PsA followed in university or peripheral hospitals or peripheral private practices with experience in AS and PsA care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\>= 18 years and \\<= 50 years\n* Patient diagnosed with AS or PsA\n* Patient to be initiated on adalimumab (according to the Marketing Authorization and Belgian reimbursement criteria)\n* Patient willing to sign informed consent\n\nExclusion Criteria:\n\n* Any contraindication for adalimumab as specified in the corresponding Summary of Product Characteristics (SmPC)\n* Patient previously treated with biologics\n* Patient participating in other AbbVie-sponsored trials'}, 'identificationModule': {'nctId': 'NCT01845818', 'acronym': 'SPACTIVE', 'briefTitle': 'Study in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Observational Study in AS and PsA Patients to Evaluate Work Productivity Before and After the Start of Adalimumab Therapy in Daily Practice in Belgium', 'orgStudyIdInfo': {'id': 'P13-990'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ankylosing Spondylitis and Psoriatic Arthritis', 'description': 'Participants with AS and PsA and in whom adalimumab treatment is initiated. All medication will be prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}