Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-27 @ 2:15 AM
Study NCT ID:
NCT01083693
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2010-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D000844', 'term': 'Ankylosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.', 'description': 'A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.', 'eventGroups': [{'id': 'EG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.', 'otherNumAtRisk': 93, 'otherNumAffected': 10, 'seriousNumAtRisk': 93, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.', 'otherNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.', 'otherNumAtRisk': 40, 'otherNumAffected': 1, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Total', 'otherNumAtRisk': 161, 'otherNumAffected': 12, 'seriousNumAtRisk': 161, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Uriticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Synovectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post procedural sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthroscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Total'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Early Termination', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': "The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]) in each disease group.'}, {'type': 'PRIMARY', 'title': 'SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG003', 'title': 'Total'}], 'classes': [{'title': 'Physical Functioning -Baseline', 'categories': [{'measurements': [{'value': '51.4', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '53.3', 'spread': '23.4', 'groupId': 'OG002'}, {'value': '53.1', 'spread': '25.6', 'groupId': 'OG003'}]}]}, {'title': 'Physical Functioning - 3 months', 'categories': [{'measurements': [{'value': '67.4', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '74.3', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '76.5', 'spread': '21.9', 'groupId': 'OG002'}, {'value': '71.0', 'spread': '23.4', 'groupId': 'OG003'}]}]}, {'title': 'Physical Functioning - 6 months', 'categories': [{'measurements': [{'value': '65.3', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '76.0', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '79.4', 'spread': '22.2', 'groupId': 'OG002'}, {'value': '70.9', 'spread': '24.1', 'groupId': 'OG003'}]}]}, {'title': 'Physical Functioning - 9 months', 'categories': [{'measurements': [{'value': '67.4', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '79.8', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '81.4', 'spread': '18.7', 'groupId': 'OG002'}, {'value': '73.4', 'spread': '23.1', 'groupId': 'OG003'}]}]}, {'title': 'Physical Functioning -12 months', 'categories': [{'measurements': [{'value': '70.3', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '85.9', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '80.4', 'spread': '24.5', 'groupId': 'OG002'}, {'value': '75.9', 'spread': '23.1', 'groupId': 'OG003'}]}]}, {'title': 'Physical Functioning - Early Termination', 'categories': [{'measurements': [{'value': '33.3', 'spread': '28.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '33.3', 'spread': '28.6', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning -Physical - Baseline', 'categories': [{'measurements': [{'value': '29.8', 'spread': '40.5', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '43.5', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '32.2', 'groupId': 'OG002'}, {'value': '30.3', 'spread': '39.2', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning - Physical - 3 months', 'categories': [{'measurements': [{'value': '57.3', 'spread': '43.5', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '41.0', 'groupId': 'OG001'}, {'value': '67.4', 'spread': '38.8', 'groupId': 'OG002'}, {'value': '60.2', 'spread': '41.8', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning - Physical - 6 months', 'categories': [{'measurements': [{'value': '55.3', 'spread': '44.0', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '36.8', 'groupId': 'OG001'}, {'value': '73.4', 'spread': '37.6', 'groupId': 'OG002'}, {'value': '62.7', 'spread': '41.7', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning - Physical - 9 months', 'categories': [{'measurements': [{'value': '55.4', 'spread': '43.7', 'groupId': 'OG000'}, {'value': '72.5', 'spread': '40.5', 'groupId': 'OG001'}, {'value': '75.0', 'spread': '37.2', 'groupId': 'OG002'}, {'value': '63.8', 'spread': '42.1', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning - Physical - 12 months', 'categories': [{'measurements': [{'value': '59.8', 'spread': '42.3', 'groupId': 'OG000'}, {'value': '85.0', 'spread': '28.6', 'groupId': 'OG001'}, {'value': '75.9', 'spread': '38.9', 'groupId': 'OG002'}, {'value': '68.9', 'spread': '40.1', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning - Physical - Early Termination', 'categories': [{'measurements': [{'value': '29.2', 'spread': '40.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '29.2', 'spread': '40.1', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain - Baseline', 'categories': [{'measurements': [{'value': '33.6', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '23.9', 'groupId': 'OG001'}, {'value': '27.7', 'spread': '19.1', 'groupId': 'OG002'}, {'value': '32.7', 'spread': '20.2', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain- 3 months', 'categories': [{'measurements': [{'value': '56.5', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '66.1', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '59.8', 'spread': '24.5', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain- 6 months', 'categories': [{'measurements': [{'value': '53.9', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '64.9', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '67.7', 'spread': '25.2', 'groupId': 'OG002'}, {'value': '59.5', 'spread': '22.8', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain- 9 months', 'categories': [{'measurements': [{'value': '59.5', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '69.8', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '64.0', 'spread': '23.0', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain- 12 months', 'categories': [{'measurements': [{'value': '62.5', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '74.0', 'spread': '23.2', 'groupId': 'OG001'}, {'value': '71.2', 'spread': '27.9', 'groupId': 'OG002'}, {'value': '67.0', 'spread': '22.8', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain- Early Termination', 'categories': [{'measurements': [{'value': '25.7', 'spread': '37.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '25.7', 'spread': '37.6', 'groupId': 'OG003'}]}]}, {'title': 'General Health - Baseline', 'categories': [{'measurements': [{'value': '42.9', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '39.1', 'spread': '16.4', 'groupId': 'OG002'}, {'value': '41.8', 'spread': '18.6', 'groupId': 'OG003'}]}]}, {'title': 'General Health - 3 months', 'categories': [{'measurements': [{'value': '51.7', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '53.0', 'spread': '20.8', 'groupId': 'OG001'}, {'value': '59.0', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '53.8', 'spread': '19.5', 'groupId': 'OG003'}]}]}, {'title': 'General Health - 6 months', 'categories': [{'measurements': [{'value': '54.0', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '60.1', 'spread': '23.7', 'groupId': 'OG002'}, {'value': '57.0', 'spread': '19.1', 'groupId': 'OG003'}]}]}, {'title': 'General Health - 9 months', 'categories': [{'measurements': [{'value': '54.9', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '59.8', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '65.7', 'spread': '22.1', 'groupId': 'OG002'}, {'value': '58.7', 'spread': '20.3', 'groupId': 'OG003'}]}]}, {'title': 'General Health - 12 months', 'categories': [{'measurements': [{'value': '59.5', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '65.0', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '66.3', 'spread': '23.0', 'groupId': 'OG002'}, {'value': '62.3', 'spread': '20.7', 'groupId': 'OG003'}]}]}, {'title': 'General Health - Early Termination', 'categories': [{'measurements': [{'value': '39.0', 'spread': '26.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '39.0', 'spread': '26.2', 'groupId': 'OG003'}]}]}, {'title': 'Vitality - Baseline', 'categories': [{'measurements': [{'value': '39.3', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '39.8', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '32.4', 'spread': '18.7', 'groupId': 'OG002'}, {'value': '37.7', 'spread': '19.5', 'groupId': 'OG003'}]}]}, {'title': 'Vitality - 3 months', 'categories': [{'measurements': [{'value': '53.6', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '54.5', 'spread': '20.4', 'groupId': 'OG002'}, {'value': '53.8', 'spread': '19.5', 'groupId': 'OG003'}]}]}, {'title': 'Vitality - 6 months', 'categories': [{'measurements': [{'value': '52.6', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '56.8', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '57.9', 'spread': '19.4', 'groupId': 'OG002'}, {'value': '54.7', 'spread': '17.5', 'groupId': 'OG003'}]}]}, {'title': 'Vitality - 9 months', 'categories': [{'measurements': [{'value': '52.3', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '56.3', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '59.2', 'spread': '20.1', 'groupId': 'OG002'}, {'value': '54.9', 'spread': '19.0', 'groupId': 'OG003'}]}]}, {'title': 'Vitality - 12 months', 'categories': [{'measurements': [{'value': '56.9', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '65.0', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '58.0', 'spread': '21.5', 'groupId': 'OG002'}, {'value': '58.7', 'spread': '18.4', 'groupId': 'OG003'}]}]}, {'title': 'Vitality - Early Termination', 'categories': [{'measurements': [{'value': '23.3', 'spread': '16.3', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '23.3', 'spread': '16.3', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning - Baseline', 'categories': [{'measurements': [{'value': '59.5', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '31.2', 'groupId': 'OG001'}, {'value': '52.8', 'spread': '25.0', 'groupId': 'OG002'}, {'value': '59.1', 'spread': '29.2', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning - 3 months', 'categories': [{'measurements': [{'value': '75.3', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '78.0', 'spread': '21.4', 'groupId': 'OG002'}, {'value': '76.8', 'spread': '20.6', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning - 6 months', 'categories': [{'measurements': [{'value': '78.4', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '85.7', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '81.0', 'spread': '23.0', 'groupId': 'OG002'}, {'value': '80.4', 'spread': '21.0', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning - 9 months', 'categories': [{'measurements': [{'value': '79.0', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '86.9', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '83.2', 'spread': '23.2', 'groupId': 'OG002'}, {'value': '81.5', 'spread': '20.8', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning - 12 months', 'categories': [{'measurements': [{'value': '82.3', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '80.4', 'spread': '25.1', 'groupId': 'OG002'}, {'value': '83.8', 'spread': '21.1', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning - Early Termination', 'categories': [{'measurements': [{'value': '47.9', 'spread': '31.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '47.9', 'spread': '31.0', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning -Emotional - Baseline', 'categories': [{'measurements': [{'value': '45.1', 'spread': '44.7', 'groupId': 'OG000'}, {'value': '55.6', 'spread': '43.4', 'groupId': 'OG001'}, {'value': '40.7', 'spread': '42.2', 'groupId': 'OG002'}, {'value': '46.0', 'spread': '43.8', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning -Emotional - 3 months', 'categories': [{'measurements': [{'value': '66.2', 'spread': '42.3', 'groupId': 'OG000'}, {'value': '75.4', 'spread': '41.7', 'groupId': 'OG001'}, {'value': '74.0', 'spread': '35.7', 'groupId': 'OG002'}, {'value': '69.8', 'spread': '40.5', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning -Emotional - 6 months', 'categories': [{'measurements': [{'value': '69.7', 'spread': '41.2', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '35.9', 'groupId': 'OG001'}, {'value': '76.3', 'spread': '36.7', 'groupId': 'OG002'}, {'value': '73.7', 'spread': '39.2', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning -Emotional - 9 months', 'categories': [{'measurements': [{'value': '72.4', 'spread': '40.5', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '39.4', 'groupId': 'OG001'}, {'value': '81.6', 'spread': '31.6', 'groupId': 'OG002'}, {'value': '76.0', 'spread': '38.0', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning -Emotional - 12 months', 'categories': [{'measurements': [{'value': '78.2', 'spread': '37.0', 'groupId': 'OG000'}, {'value': '91.7', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '75.0', 'spread': '38.1', 'groupId': 'OG002'}, {'value': '79.9', 'spread': '35.7', 'groupId': 'OG003'}]}]}, {'title': 'Role Functioning - Emotional - Early Termination', 'categories': [{'measurements': [{'value': '33.3', 'spread': '51.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '33.3', 'spread': '51.6', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health - Baseline', 'categories': [{'measurements': [{'value': '55.6', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '63.1', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '53.9', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '56.6', 'spread': '21.6', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health - 3 months', 'categories': [{'measurements': [{'value': '66.1', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '70.1', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '70.4', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '67.9', 'spread': '18.9', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health - 6 months', 'categories': [{'measurements': [{'value': '67.9', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '73.6', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '70.8', 'spread': '17.3', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health - 9 months', 'categories': [{'measurements': [{'value': '70.7', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '74.6', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '76.1', 'spread': '18.8', 'groupId': 'OG002'}, {'value': '72.9', 'spread': '18.6', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health - 12 months', 'categories': [{'measurements': [{'value': '73.2', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '81.8', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '76.7', 'spread': '17.2', 'groupId': 'OG002'}, {'value': '75.8', 'spread': '15.5', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health - Early Termination', 'categories': [{'measurements': [{'value': '41.3', 'spread': '23.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '41.3', 'spread': '23.8', 'groupId': 'OG003'}]}]}, {'title': 'Reported Health Transition - Baseline', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Reported Health Transition - 3 months', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'Reported Health Transition - 6 months', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '1.0', 'groupId': 'OG003'}]}]}, {'title': 'Reported Health Transition - 9 months', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Reported Health Transition - 12 months', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Reported Health Transition - Early Termination', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Score not available as there were no participants who had an early termination visit in this group.', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '2.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[participants who discontinued the study early\\]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.'}, {'type': 'PRIMARY', 'title': 'EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG003', 'title': 'Total'}], 'classes': [{'title': 'EQ-5D - Baseline', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG003'}]}]}, {'title': 'EQ-5D - 3 months', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'EQ-5D - 6 months', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'EQ-5D - 9 months', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'EQ-5D - 12 months', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'EQ-5D - Early Termination', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Only one patient completed this assessment at an early termination visit therefore a standard deviation value is not available.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were no patients who completed this assessment at an early termination visit in this group/arm.', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG003'}]}]}, {'title': 'Thermometer Scale - Baseline', 'categories': [{'measurements': [{'value': '49.0', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '40.2', 'spread': '22.6', 'groupId': 'OG002'}, {'value': '47.4', 'spread': '22.7', 'groupId': 'OG003'}]}]}, {'title': 'Thermometer Scale - 3 months', 'categories': [{'measurements': [{'value': '64.8', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '68.7', 'spread': '21.0', 'groupId': 'OG001'}, {'value': '64.9', 'spread': '25.6', 'groupId': 'OG002'}, {'value': '65.5', 'spread': '22.7', 'groupId': 'OG003'}]}]}, {'title': 'Thermometer Scale - 6 months', 'categories': [{'measurements': [{'value': '59.5', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '68.9', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '68.7', 'spread': '29.0', 'groupId': 'OG002'}, {'value': '63.7', 'spread': '24.5', 'groupId': 'OG003'}]}]}, {'title': 'Thermometer Scale - 9 months', 'categories': [{'measurements': [{'value': '67.5', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '67.8', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '69.2', 'spread': '25.0', 'groupId': 'OG002'}, {'value': '68.0', 'spread': '22.8', 'groupId': 'OG003'}]}]}, {'title': 'Thermometer Scale - 12 months', 'categories': [{'measurements': [{'value': '73.2', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '79.2', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '71.5', 'spread': '28.5', 'groupId': 'OG002'}, {'value': '73.9', 'spread': '21.2', 'groupId': 'OG003'}]}]}, {'title': 'Thermometer Scale - Early Termination', 'categories': [{'measurements': [{'value': '67.2', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '100.0', 'spread': 'NA', 'comment': 'Only one patient completed this assessment at an early termination visit therefore a standard deviation value is not available.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were no patients who completed this assessment at an early termination visit in this group/arm.', 'groupId': 'OG002'}, {'value': '71.9', 'spread': '29.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).\n\nIn addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]) in each disease group.'}, {'type': 'SECONDARY', 'title': 'DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Total'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Early Termination', 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,months 3,6,9,12', 'description': "The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]) in each disease group.'}, {'type': 'SECONDARY', 'title': 'Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Early Termination', 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]).'}, {'type': 'SECONDARY', 'title': "Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only", 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Total'}], 'classes': [{'title': "Physician's PGA - Baseline", 'categories': [{'measurements': [{'value': '55.1', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '52.0', 'spread': '26.9', 'groupId': 'OG001'}, {'value': '54.4', 'spread': '21.4', 'groupId': 'OG002'}]}]}, {'title': "Physician's PGA - 3 months", 'categories': [{'measurements': [{'value': '28.8', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '29.0', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '20.8', 'groupId': 'OG002'}]}]}, {'title': "Physician's PGA - 6 months", 'categories': [{'measurements': [{'value': '29.5', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': "Physician's PGA - 9 months", 'categories': [{'measurements': [{'value': '28.6', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '26.1', 'spread': '18.7', 'groupId': 'OG002'}]}]}, {'title': "Physician's PGA - 12 months", 'categories': [{'measurements': [{'value': '22.9', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '22.1', 'spread': '16.3', 'groupId': 'OG002'}]}]}, {'title': "Physician's PGA - Early Termination", 'categories': [{'measurements': [{'value': '57.0', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '47.3', 'spread': '33.4', 'groupId': 'OG002'}]}]}, {'title': "Patient's PGA - Baseline", 'categories': [{'measurements': [{'value': '60.0', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '59.6', 'spread': '24.3', 'groupId': 'OG002'}]}]}, {'title': "Patient's PGA - 3 months", 'categories': [{'measurements': [{'value': '32.4', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '22.3', 'groupId': 'OG001'}, {'value': '32.8', 'spread': '22.7', 'groupId': 'OG002'}]}]}, {'title': "Patient's PGA - 6 months", 'categories': [{'measurements': [{'value': '32.1', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '31.1', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': "Patient's PGA - 9 months", 'categories': [{'measurements': [{'value': '32.2', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '29.9', 'spread': '20.6', 'groupId': 'OG002'}]}]}, {'title': "Patient's PGA - 12 months", 'categories': [{'measurements': [{'value': '26.1', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '25.6', 'spread': '17.8', 'groupId': 'OG002'}]}]}, {'title': "Patient's PGA - Early Termination", 'categories': [{'measurements': [{'value': '63.2', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '29.3', 'groupId': 'OG001'}, {'value': '54.9', 'spread': '33.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': "Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]) in each disease group.'}, {'type': 'SECONDARY', 'title': "Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only", 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Total'}], 'classes': [{'title': "Physician's GH - Baseline", 'categories': [{'measurements': [{'value': '51.4', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '50.4', 'spread': '21.6', 'groupId': 'OG002'}]}]}, {'title': "Physician's GH -3 months", 'categories': [{'measurements': [{'value': '29.9', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '21.6', 'groupId': 'OG002'}]}]}, {'title': "Physician's GH - 6 months", 'categories': [{'measurements': [{'value': '31.5', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '23.9', 'groupId': 'OG001'}, {'value': '30.4', 'spread': '21.9', 'groupId': 'OG002'}]}]}, {'title': "Physician's GH - 9 months", 'categories': [{'measurements': [{'value': '31.3', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '24.5', 'groupId': 'OG001'}, {'value': '30.2', 'spread': '22.8', 'groupId': 'OG002'}]}]}, {'title': "Physician's GH - 12 months", 'categories': [{'measurements': [{'value': '29.0', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '26.7', 'groupId': 'OG001'}, {'value': '28.3', 'spread': '24.6', 'groupId': 'OG002'}]}]}, {'title': "Physician's GH - Early Termination", 'categories': [{'measurements': [{'value': '56.2', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '46.6', 'spread': '31.8', 'groupId': 'OG002'}]}]}, {'title': "Patient's GH - Baseline", 'categories': [{'measurements': [{'value': '55.3', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '59.0', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '56.1', 'spread': '25.2', 'groupId': 'OG002'}]}]}, {'title': "Patient's GH -3 months", 'categories': [{'measurements': [{'value': '33.6', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '33.1', 'spread': '23.2', 'groupId': 'OG002'}]}]}, {'title': "Patient's GH - 6 months", 'categories': [{'measurements': [{'value': '32.9', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '32.1', 'spread': '23.2', 'groupId': 'OG002'}]}]}, {'title': "Patient's GH -9 months", 'categories': [{'measurements': [{'value': '35.0', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '33.2', 'spread': '23.0', 'groupId': 'OG002'}]}]}, {'title': "Patient's GH -12 months", 'categories': [{'measurements': [{'value': '30.4', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '25.7', 'groupId': 'OG001'}, {'value': '30.4', 'spread': '24.0', 'groupId': 'OG002'}]}]}, {'title': "Patient's GH - Early Termination", 'categories': [{'measurements': [{'value': '62.5', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '29.3', 'groupId': 'OG001'}, {'value': '53.8', 'spread': '35.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': "Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]) in each disease group.'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG003', 'title': 'Total'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.8', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '25.2', 'spread': '15.7', 'groupId': 'OG002'}, {'value': '32.4', 'spread': '21.2', 'groupId': 'OG003'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '25.3', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '12.3', 'groupId': 'OG002'}, {'value': '20.6', 'spread': '18.8', 'groupId': 'OG003'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '23.9', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '11.9', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '19.0', 'spread': '19.2', 'groupId': 'OG003'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '24.2', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '11.9', 'spread': '8.4', 'groupId': 'OG002'}, {'value': '19.1', 'spread': '19.4', 'groupId': 'OG003'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '18.3', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '12.8', 'groupId': 'OG002'}, {'value': '15.9', 'spread': '12.7', 'groupId': 'OG003'}]}]}, {'title': 'Early termination', 'categories': [{'measurements': [{'value': '47.3', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '26.5', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '37.3', 'spread': '30.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]) in each disease group.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'OG003', 'title': 'Total'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'categories': [{'measurements': [{'value': '3.5', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '4.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \\[for participants who discontinued the study early\\]) in each disease group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'FG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'FG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of effectiveness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Patient Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Complete remission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other medical condition/surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Reason unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 162 participants were screened for this study. Of those, 161 are included in the analysis as one participant was a screen failure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'BG001', 'title': 'Psoriasis Arthritis (PsA)', 'description': 'Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'BG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '47.9', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '12.9', 'groupId': 'BG002'}, {'value': '50.9', 'spread': '14.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of underlying disease', 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '6.2', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '11.4', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '8.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Average duration (years) of underlying disease', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-09', 'studyFirstSubmitDate': '2010-02-28', 'resultsFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-28', 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': "The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do)."}, {'measure': 'SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).'}, {'measure': 'EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).\n\nIn addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.'}], 'secondaryOutcomes': [{'measure': 'DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale', 'timeFrame': 'Baseline,months 3,6,9,12', 'description': "The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value)."}, {'measure': 'Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.'}, {'measure': "Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only", 'timeFrame': 'Baseline, months 3,6,9,12', 'description': "Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity)."}, {'measure': "Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only", 'timeFrame': 'Baseline, months 3,6,9,12', 'description': "Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state)."}, {'measure': 'Erythrocyte Sedimentation Rate', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.'}, {'measure': 'C-Reactive Protein', 'timeFrame': 'Baseline, months 3,6,9,12', 'description': 'The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Monoclonals', 'Antibodies', 'Ankylosing Spondylitis', 'Antirheumatic Agents', 'Quality of Life', 'Adalimumab', 'rheumatoid arthritis', 'psoriatic arthritis'], 'conditions': ['Rheumatoid Arthritis', 'Ankylosing Spondylitis', 'Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic and medical practice specialized in rheumatology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age greater than or equal to 18\n* Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis).\n\nIn addition one of the following criteria must be fulfilled:\n\n* unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA\n* unsatisfactory NSAID response in patients with AS or\n* unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS.\n\nExclusion Criteria:\n\n* Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC\n* Patients participating in another study or clinical trial.'}, 'identificationModule': {'nctId': 'NCT01083693', 'briefTitle': 'Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'An Open Label Multicenter Post Marketing Observational Study for the Evaluation of Quality of Life Outcomes and Tolerability of HUMIRA in Routine Clinical Use in Patients With RA PsA AS After Unsustainable Response to Disease Modifying Antirheumatic Drugs and or Biologicals', 'orgStudyIdInfo': {'id': 'P10-726'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid, Psoriatic Arthritis, Ankylosing Spondylitis', 'description': 'Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, patients with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-3300', 'city': 'Amstetten', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32372', 'geoPoint': {'lat': 48.1229, 'lon': 14.87206}}, {'zip': 'A-6700', 'city': 'Bludenz', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32368', 'geoPoint': {'lat': 47.15476, 'lon': 9.82255}}, {'zip': 'A-2640', 'city': 'Gloggnitz', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32367', 'geoPoint': {'lat': 47.67487, 'lon': 15.93893}}, {'zip': 'A-8020', 'city': 'Graz', 'country': 'Austria', 'facility': 'Site Ref # / Investigator 37123', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Site Ref # / Investigator 37125', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'A-9020', 'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32375', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32365', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32369', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32371', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32376', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-2351', 'city': 'Neudorf', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32373', 'geoPoint': {'lat': 47.15984, 'lon': 15.75482}}, {'zip': 'A-5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32364', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': 'A-1030', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 18782', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1030', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32363', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32377', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32378', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32366', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-4840', 'city': 'Vöcklabruck', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32374', 'geoPoint': {'lat': 48.00279, 'lon': 13.65652}}, {'zip': 'A-8160', 'city': 'Weiz', 'country': 'Austria', 'facility': 'Site Reference ID/Investigator # 32370', 'geoPoint': {'lat': 47.21667, 'lon': 15.61667}}, {'zip': 'A-4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Site Ref # / Investigator 37124', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}], 'overallOfficials': [{'name': 'Astrid Dworan-Timler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott AUSTRIA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Group Data Management Biostatistics', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr. Astrid Dworan-Timler, Medical Director', 'oldOrganization': 'Abbott AUSTRIA'}}}}