Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT01756235
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bosnia and Herzegovina', 'Estonia', 'Hungary', 'Romania', 'Russia', 'Serbia', 'Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Information', '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': "Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.", 'description': 'Non serious adverse events were not collected for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 460, 'seriousNumAffected': 32}], 'seriousEvents': [{'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'NO THERAPEUTIC RESPONSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CYTOMEGALOVIRUS HEPATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HERPES OPHTHALMIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LOCALISED INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PULMONARY TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'VAGINAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LUPUS-LIKE SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LUNG ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PANCREATIC CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INTERCOSTAL NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PHOTODERMATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SKIN DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '870.0', 'spread': '4517.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Physical Activity SQUASH Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 3 (N=356)', 'categories': [{'measurements': [{'value': '454.9', 'spread': '3553.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=316)', 'categories': [{'measurements': [{'value': '648.2', 'spread': '3565.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=273)', 'categories': [{'measurements': [{'value': '611.3', 'spread': '4130.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6 and Month 9', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in SQUASH-A Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 3 (N=368)', 'categories': [{'measurements': [{'value': '-91.6', 'spread': '950.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=327)', 'categories': [{'measurements': [{'value': '-41.7', 'spread': '957.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=281)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1052.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=265)', 'categories': [{'measurements': [{'value': '10.4', 'spread': '880.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=382)', 'categories': [{'measurements': [{'value': '-35.7', 'spread': '1043.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in SQUASH-B Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 3 (N=359)', 'categories': [{'measurements': [{'value': '399.5', 'spread': '2729.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=319)', 'categories': [{'measurements': [{'value': '497.9', 'spread': '2375', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=277)', 'categories': [{'measurements': [{'value': '358.9', 'spread': '2720.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=257)', 'categories': [{'measurements': [{'value': '831.3', 'spread': '3450.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=375)', 'categories': [{'measurements': [{'value': '578.0', 'spread': '3131.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in SQUASH-C Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 3 (N=364)', 'categories': [{'measurements': [{'value': '81.4', 'spread': '1507.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=325)', 'categories': [{'measurements': [{'value': '154.6', 'spread': '1516.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=281)', 'categories': [{'measurements': [{'value': '98.5', 'spread': '1590.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=261)', 'categories': [{'measurements': [{'value': '315.4', 'spread': '1750', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=379)', 'categories': [{'measurements': [{'value': '196.9', 'spread': '1725.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in SQUASH-D Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 3 (N=370)', 'categories': [{'measurements': [{'value': '47.3', 'spread': '823.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=330)', 'categories': [{'measurements': [{'value': '27.2', 'spread': '1102.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=284)', 'categories': [{'measurements': [{'value': '170.2', 'spread': '1263.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=266)', 'categories': [{'measurements': [{'value': '136.2', 'spread': '1733.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=382)', 'categories': [{'measurements': [{'value': '96.4', 'spread': '1536.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 3 (N=431)', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=390)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=362)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=334)', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=433)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \\>5.1 indicates high disease activity, a DAS28 score \\<3.2 indicates low disease activity, and a DAS28 score \\<2.6 indicates clinical remission.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Clinical Disease Remission (DAS28<2.6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 0 (N=459)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (N=432)', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=390)', 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=362)', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=334)', 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=434)', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 0 (N=459)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (N=432)', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=390)', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=362)', 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=334)', 'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=434)', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH (Month 3, N=198)', 'categories': [{'measurements': [{'value': '473.3', 'spread': '3417.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 3, N=204)', 'categories': [{'measurements': [{'value': '-57.5', 'spread': '609.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 3, N=200)', 'categories': [{'measurements': [{'value': '438.3', 'spread': '2480.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 3, N=200)', 'categories': [{'measurements': [{'value': '87.0', 'spread': '1617.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 3, N=205)', 'categories': [{'measurements': [{'value': '-11.3', 'spread': '762.1', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 6, N=181)', 'categories': [{'measurements': [{'value': '979.8', 'spread': '3567.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 6, N=187)', 'categories': [{'measurements': [{'value': '-23.2', 'spread': '724.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 6, N=183)', 'categories': [{'measurements': [{'value': '761.0', 'spread': '2383.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 6, N=186)', 'categories': [{'measurements': [{'value': '234.5', 'spread': '1518.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 6, N=189)', 'categories': [{'measurements': [{'value': '-8.6', 'spread': '1142.7', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 9, N=162)', 'categories': [{'measurements': [{'value': '1209.8', 'spread': '4126.9', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 9, N=165)', 'categories': [{'measurements': [{'value': '130.3', 'spread': '874.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 9, N=164)', 'categories': [{'measurements': [{'value': '707.2', 'spread': '2815.5', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 9, N=165)', 'categories': [{'measurements': [{'value': '255.9', 'spread': '1713.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 9, N=167)', 'categories': [{'measurements': [{'value': '142.4', 'spread': '1298.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 12, N=167)', 'categories': [{'measurements': [{'value': '1912.4', 'spread': '4592.1', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 12, N=171)', 'categories': [{'measurements': [{'value': '80.7', 'spread': '724.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 12, N=167)', 'categories': [{'measurements': [{'value': '1158.7', 'spread': '3168.1', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 12, N=169)', 'categories': [{'measurements': [{'value': '470.7', 'spread': '1898.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 12, N=171)', 'categories': [{'measurements': [{'value': '171.6', 'spread': '1905.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 12 LOCF, N=211)', 'categories': [{'measurements': [{'value': '1494.8', 'spread': '4513.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 12 LOCF, N=214)', 'categories': [{'measurements': [{'value': '53.4', 'spread': '860.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 12 LOCF, N=211)', 'categories': [{'measurements': [{'value': '964.5', 'spread': '3127.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 12 LOCF, N=212)', 'categories': [{'measurements': [{'value': '367.5', 'spread': '1808.5', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 12 LOCF, N=214)', 'categories': [{'measurements': [{'value': '90.0', 'spread': '1778.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH (Month 3, N=157)', 'categories': [{'measurements': [{'value': '434.5', 'spread': '3739.9', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 3, N=163)', 'categories': [{'measurements': [{'value': '-134.8', 'spread': '1255.7', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 3, N=158)', 'categories': [{'measurements': [{'value': '352.9', 'spread': '3029.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 3, N=163)', 'categories': [{'measurements': [{'value': '75.1', 'spread': '1370.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 3, N=164)', 'categories': [{'measurements': [{'value': '120.7', 'spread': '893.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 6, N=135)', 'categories': [{'measurements': [{'value': '203.6', 'spread': '3526.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 6, N=140)', 'categories': [{'measurements': [{'value': '-66.5', 'spread': '1202.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 6, N=136)', 'categories': [{'measurements': [{'value': '143.9', 'spread': '2325.7', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 6, N=139)', 'categories': [{'measurements': [{'value': '47.6', 'spread': '1512.2', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 6, N=141)', 'categories': [{'measurements': [{'value': '75.1', 'spread': '1047.9', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 9, N=111)', 'categories': [{'measurements': [{'value': '-262.1', 'spread': '3995.1', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 9, N=116)', 'categories': [{'measurements': [{'value': '-176.9', 'spread': '1245.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 9, N=113)', 'categories': [{'measurements': [{'value': '-146.6', 'spread': '2503.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 9, N=116)', 'categories': [{'measurements': [{'value': '-125.5', 'spread': '1373.1', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 9, N=117)', 'categories': [{'measurements': [{'value': '209.8', 'spread': '1216.5', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 12, N=88)', 'categories': [{'measurements': [{'value': '230.7', 'spread': '4924.9', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 12, N=94)', 'categories': [{'measurements': [{'value': '-117.6', 'spread': '1102.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 12, N=90)', 'categories': [{'measurements': [{'value': '223.9', 'spread': '3867.2', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 12, N=92)', 'categories': [{'measurements': [{'value': '30.1', 'spread': '1403.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 12, N=95)', 'categories': [{'measurements': [{'value': '72.4', 'spread': '1377.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 12 LOCF, N=162)', 'categories': [{'measurements': [{'value': '61.6', 'spread': '4420.2', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 12 LOCF, N=167)', 'categories': [{'measurements': [{'value': '-150.2', 'spread': '1235.1', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 12 LOCF, N=163)', 'categories': [{'measurements': [{'value': '81.3', 'spread': '3083.7', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 12 LOCF, N=166)', 'categories': [{'measurements': [{'value': '-19.8', 'spread': '1599.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 12 LOCF, N=167)', 'categories': [{'measurements': [{'value': '105.1', 'spread': '1166.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'Month 3 (N=384)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (N=345)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (N=300)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=284)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 LOCF (N=396)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores", 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH and DAS28 (Month 0, N=423)', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH and DAS28 (Month 12 LOCF, N=386)', 'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A and DAS28 (Month 0, N=431)', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A and DAS28 (Month 12 LOCF, N=386)', 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B and DAS28 (Month 0, N=424)', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B and DAS28 (Month 12 LOCF, N=386)', 'categories': [{'measurements': [{'value': '-0.17', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C and DAS28 (Month 0, N=429)', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C and DAS28 (Month 12 LOCF, N=386)', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D and DAS28 (Month 0, N=432)', 'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D and DAS28 (Month 12 LOCF, N=386)', 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity.', 'unitOfMeasure': 'Correlation coeficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores", 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH (Month 0, N=421)', 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Month 12 LOCF, N=385)', 'categories': [{'measurements': [{'value': '-0.22', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 0, N=429)', 'categories': [{'measurements': [{'value': '-0.16', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Month 12 LOCF, N=385)', 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 0, N=422)', 'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Month 12 LOCF, N=385)', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 0, N=427)', 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Month 12 LOCF, N=385)', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 0, N=430)', 'categories': [{'measurements': [{'value': '-0.14', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Month 12 LOCF, N=385)', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity.', 'unitOfMeasure': 'Correlation coeficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories", 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH (<65 years, N=297)', 'categories': [{'measurements': [{'value': '1066.2', 'spread': '4456.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (>=65 years, N=77)', 'categories': [{'measurements': [{'value': '113.1', 'spread': '4699.9', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH A (<65 years, N=302)', 'categories': [{'measurements': [{'value': '-27.5', 'spread': '1066.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH A (>=65 years, N=80)', 'categories': [{'measurements': [{'value': '-66.7', 'spread': '956.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH B (<65 years, N=298)', 'categories': [{'measurements': [{'value': '770.8', 'spread': '2850.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH B (>=65 years, N=77)', 'categories': [{'measurements': [{'value': '-167.8', 'spread': '3972.9', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH C (<65 years, N=300)', 'categories': [{'measurements': [{'value': '189.5', 'spread': '1779.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH C (>=65 years, N=79)', 'categories': [{'measurements': [{'value': '225.0', 'spread': '1514.7', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH D (<65 years, N=302)', 'categories': [{'measurements': [{'value': '103.8', 'spread': '1691.5', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH D (>=65 years, N=80)', 'categories': [{'measurements': [{'value': '68.3', 'spread': '697.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender", 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH (Male, N=70)', 'categories': [{'measurements': [{'value': '1500.1', 'spread': '5026.2', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Female, N=304)', 'categories': [{'measurements': [{'value': '724.9', 'spread': '4388.7', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Male, N=70)', 'categories': [{'measurements': [{'value': '-133.9', 'spread': '1091.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Female, N=312)', 'categories': [{'measurements': [{'value': '-13.7', 'spread': '1032.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Male, N=70)', 'categories': [{'measurements': [{'value': '948.3', 'spread': '3565.2', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Female, N=305)', 'categories': [{'measurements': [{'value': '493.0', 'spread': '3022.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Male, N=70)', 'categories': [{'measurements': [{'value': '344.7', 'spread': '1774.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Female, N=309)', 'categories': [{'measurements': [{'value': '163.4', 'spread': '1716.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Male, N=70)', 'categories': [{'measurements': [{'value': '264.6', 'spread': '1719.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Female, N=312)', 'categories': [{'measurements': [{'value': '58.6', 'spread': '1493.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education", 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH (High School, N=195)', 'categories': [{'measurements': [{'value': '831.7', 'spread': '3946.1', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Lower than High School, N=179)', 'categories': [{'measurements': [{'value': '911.8', 'spread': '5079.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (High School, N=198)', 'categories': [{'measurements': [{'value': '-45.2', 'spread': '926.9', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Lower than High School, N=184)', 'categories': [{'measurements': [{'value': '-25.5', 'spread': '1158.0', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (High School, N=195)', 'categories': [{'measurements': [{'value': '520.5', 'spread': '2187.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Lower than High School, N=180)', 'categories': [{'measurements': [{'value': '640.4', 'spread': '3910.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (High School, N=198)', 'categories': [{'measurements': [{'value': '202.1', 'spread': '1751.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Lower than High School, N=181)', 'categories': [{'measurements': [{'value': '191.2', 'spread': '1702.5', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (High School, N=198)', 'categories': [{'measurements': [{'value': '131.4', 'spread': '1644.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Lower than High School, N=184)', 'categories': [{'measurements': [{'value': '58.7', 'spread': '1415.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation", 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'classes': [{'title': 'SQUASH (Manual job, N=184)', 'categories': [{'measurements': [{'value': '1235.3', 'spread': '4853.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH (Non-manual job, N=189)', 'categories': [{'measurements': [{'value': '518.4', 'spread': '4160.2', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Manual job, N=188)', 'categories': [{'measurements': [{'value': '62.2', 'spread': '977.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-A (Non-manual job, N=193)', 'categories': [{'measurements': [{'value': '-131.3', 'spread': '1100.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Manual job, N=185)', 'categories': [{'measurements': [{'value': '614.5', 'spread': '3452.2', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-B (Non-manual job, N=189)', 'categories': [{'measurements': [{'value': '544.1', 'spread': '2799.3', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Manual job, N=186)', 'categories': [{'measurements': [{'value': '456.6', 'spread': '1875.8', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-C (Non-manual job, N=192)', 'categories': [{'measurements': [{'value': '-53.0', 'spread': '1535.6', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Manual job, N=188)', 'categories': [{'measurements': [{'value': '40.1', 'spread': '1486.4', 'groupId': 'OG000'}]}]}, {'title': 'SQUASH-D (Non-manual job, N=193)', 'categories': [{'measurements': [{'value': '151.7', 'spread': '1590.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants who received at least one dose of adalimumab with evaluable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '462'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '460'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adalimumab Treatment was not Documented', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 462 participants were enrolled: 460 were in the main analysis set (MAS) population; 2 were excluded from MAS, as adalimumab treatment was not documented within this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '378', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analyses accounts for main analysis set (MAS) population (all participants who received at least 1 dose of study drug).'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2012-12-20', 'resultsFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-17', 'studyFirstPostDateStruct': {'date': '2012-12-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score', 'timeFrame': 'Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Total Physical Activity SQUASH Score', 'timeFrame': 'Month 3, Month 6 and Month 9', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': 'Mean Change From Baseline in SQUASH-A Scores', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': 'Mean Change From Baseline in SQUASH-B Scores', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': 'Mean Change From Baseline in SQUASH-C Scores', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': 'Mean Change From Baseline in SQUASH-D Scores', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': 'Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \\>5.1 indicates high disease activity, a DAS28 score \\<3.2 indicates low disease activity, and a DAS28 score \\<2.6 indicates clinical remission.'}, {'measure': 'Percentage of Participants in Clinical Disease Remission (DAS28<2.6)', 'timeFrame': 'Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.'}, {'measure': 'Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)', 'timeFrame': 'Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.'}, {'measure': "Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS", 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.'}, {'measure': "Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS", 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.'}, {'measure': 'Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score', 'timeFrame': 'Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF', 'description': 'The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement.'}, {'measure': "Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores", 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity.'}, {'measure': "Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores", 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity.'}, {'measure': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories", 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender", 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education", 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.'}, {'measure': "Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation", 'timeFrame': 'Month 0 and Month 12 LOCF', 'description': 'The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-marketing observational study (PMOS) Protocol', 'Rheumatoid Arthritis', 'Physical Activity', 'Adalimumab', 'Humira®'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate physical activity and its changes in participants with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.', 'detailedDescription': 'This post-marketing observational study was conducted in a multi-country, multi-center and single-arm format. Data were collected prospectively. Adult participants with diagnosis of RA who were assigned for treatment with adalimumab (Humira®) were eligible for participation. During this period four follow-up visits were planned for observation of the participant and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population consisted of participants with rheumatoid arthritis (RA) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had rheumatoid arthritis (RA) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines\n* Had been started on adalimumab therapy no more than one (1) month prior to the study enrolment\n* Had negative result of tuberculosis (TB) screening test or was receiving TB prophylaxis as per local guidelines\n* Had provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations\n\nExclusion Criteria:\n\n* Was unable to walk either due to RA or a comorbid condition\n* Was unable to perform basic self-care activities\n* Had contraindications for treatment with adalimumab'}, 'identificationModule': {'nctId': 'NCT01756235', 'acronym': 'PACE', 'briefTitle': 'Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)', 'orgStudyIdInfo': {'id': 'P13-683'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Rheumatoid Arthritis', 'description': 'Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elena Smirnova, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}