Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01078402
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2010-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'C563250', 'term': 'Salivary Gland Adenoma, Pleomorphic'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor, 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': 'From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis', 'otherNumAtRisk': 431, 'otherNumAffected': 0, 'seriousNumAtRisk': 431, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis', 'otherNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis', 'otherNumAtRisk': 234, 'otherNumAffected': 0, 'seriousNumAtRisk': 234, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'All Participants (RA, PsA, AS)', 'description': 'Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis', 'otherNumAtRisk': 789, 'otherNumAffected': 0, 'seriousNumAtRisk': 789, 'seriousNumAffected': 27}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 789, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Positive (DAS28 Decrease ≥1.2)', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}]}]}, {'title': 'Negative (DAS28 Decrease <1.2 or No Decrease)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months', 'description': "DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.'}, {'type': 'PRIMARY', 'title': 'Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'OG001', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Positive (BASDAI Decrease ≥50%)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}, {'title': 'Negative (BASDAI Decrease <50% or No Decrease)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months', 'description': 'BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.'}, {'type': 'SECONDARY', 'title': 'Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}, {'value': '789', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}, {'id': 'OG003', 'title': 'All Participants (RA, PsA, AS)', 'description': 'Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis'}], 'classes': [{'title': 'Score at Baseline (n=314, 81, 106, 501)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Score at 4 Months (n=232, 56, 76, 364)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Score at 7 Months (n=211, 49, 63, 323)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Score at 13 Months (n=174, 47, 31, 252)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '0.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4, 7 and 13 months', 'description': 'HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented. n=number of participants with evaluable records at given time point.'}, {'type': 'SECONDARY', 'title': 'Participant Acceptability of Self-injection at Month 13 (End of Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '782', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}, {'id': 'OG003', 'title': 'All Participants (RA, PsA, AS)', 'description': 'Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis'}], 'classes': [{'title': 'Able to Self-inject, Assessed as Convenient', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000'}, {'value': '95.9', 'groupId': 'OG001'}, {'value': '92.3', 'groupId': 'OG002'}, {'value': '89.5', 'groupId': 'OG003'}]}]}, {'title': 'Able to Self-inject, Assessed as Inconvenient', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}, {'value': '6.0', 'groupId': 'OG003'}]}]}, {'title': 'Unable to Self-inject With Need for Retraining', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Unable to Self-inject Due to Disease Condition', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '4.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '13 months', 'description': "Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.'}, {'type': 'SECONDARY', 'title': 'Compliance With the Humira Administration Schedule at Month 13 (End of Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '782', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}, {'id': 'OG003', 'title': 'All Participants (RA, PsA, AS)', 'description': 'Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '403', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '722', 'groupId': 'OG003'}]}]}, {'title': '1 Injection Missed', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': '2 Injections Missed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': '3 or More Injections Missed', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 13', 'description': 'Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.'}, {'type': 'SECONDARY', 'title': 'Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}, {'id': 'OG003', 'title': 'All Participants (RA, PsA, AS)', 'description': 'Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '29.9', 'spread': '14.1', 'groupId': 'OG002'}, {'value': '29.2', 'spread': '16.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first treatment until study discontinuation, up to 13 months.', 'description': 'Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the SES who discontinued therapy and had evaluable records. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.'}, {'type': 'SECONDARY', 'title': 'Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}, {'value': '789', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}, {'id': 'OG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'OG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}, {'id': 'OG003', 'title': 'All Participants (RA, PsA, AS)', 'description': 'Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis'}], 'classes': [{'title': 'Number of Participants with Any AE', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}]}]}, {'title': 'Number of Participants with Any SAE', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.', 'description': 'Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}, {'id': 'FG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'FG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '431'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '68'}]}]}], 'recruitmentDetails': 'Investigational sites in 7 countries participated in this study: Croatia, Hungary, Israel, Poland, Romania, Slovakia and Ukraine.', 'preAssignmentDetails': 'Out of 809 participants recruited, 789 were included in the statistical evaluation dataset (SES). 20 participants were not included due to no documented Humira therapy and/or missing primary diagnosis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '789', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rheumatoid Arthritis (RA)', 'description': 'Participants with active rheumatoid arthritis'}, {'id': 'BG001', 'title': 'Psoriatic Arthritis (PsA)', 'description': 'Participants with active psoriatic arthritis'}, {'id': 'BG002', 'title': 'Ankylosing Spondylitis (AS)', 'description': 'Participants with active ankylosing spondylitis'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '41.5', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '49.3', 'spread': '13.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '481', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '308', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease Activity Score (DAS28)', 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Low Disease Activity (score ≥2.6 and <3.2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Moderate Disease Activity (score ≥3.2 and <5.1)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'High Disease Activity (score ≥5.1)', 'categories': [{'measurements': [{'value': '376', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This assessment was for participants with RA only, per protocol.', 'groupId': 'BG002'}, {'value': '376', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': "DAS28 score is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity.", 'unitOfMeasure': 'participants'}, {'title': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score', 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This assessment was for participants with PsA and AS only, per protocol.', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'Low Disease Activity (BASDAI score <4)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This assessment was for participants with PsA and AS only, per protocol.', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'High Disease Activity (BASDAI score ≥4)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This assessment was for participants with PsA and AS only, per protocol.', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}, {'value': '270', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'BASDAI score was calculated using a questionnaire with 6 questions that participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 809}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2010-02-27', 'resultsFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2010-02-27', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-09', 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA', 'timeFrame': 'Baseline, 3 months', 'description': "DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline."}, {'measure': 'Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS', 'timeFrame': 'Baseline, 3 months', 'description': 'BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.'}], 'secondaryOutcomes': [{'measure': 'Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy', 'timeFrame': 'Baseline, 4, 7 and 13 months', 'description': 'HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.'}, {'measure': 'Participant Acceptability of Self-injection at Month 13 (End of Study)', 'timeFrame': '13 months', 'description': "Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient."}, {'measure': 'Compliance With the Humira Administration Schedule at Month 13 (End of Study)', 'timeFrame': 'Month 13', 'description': 'Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.'}, {'measure': 'Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy', 'timeFrame': 'From first treatment until study discontinuation, up to 13 months.', 'description': 'Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.'}, {'measure': 'Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.', 'description': 'Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment compliance and tolerability of Humira in patients', 'Eastern European countries', 'Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Adalimumab', 'Ankylosing Spondylitis', 'Evaluation of clinical outcome'], 'conditions': ['Ankylosing Spondylitis (AS)', 'Psoriatic Arthritis (PsA', 'Rheumatoid Arthritis (RA']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.', 'detailedDescription': 'This PMOS will be conducted in a prospective, single-arm, multicountry, multicenter format. The assignment of the patient to Humira is not decided in advance by this protocol but falls within the current practice. The prescription of Humira is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients. As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 14-17 months period (including tuberculosis (TB) screening and prophylaxis, if indicated), which defines the survey for each patient. The TB screening period per patient will be 1-4 weeks and, if applicable, the TB prophylactic treatment period before Humira administration will be 1 month in accordance with local guidelines. For indicative purposes, follow-up of patients should entail approximately 7 patient visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following TB screening. The first visit following introduction of Humira and final visits are required because of intercurrent events. If treatment with Humira is discontinued, the standard practice is to review the patient after a period of 70 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. If the physician decides to permanently discontinue Humira before the end of the planned observational period of 13 months, the reason for discontinuation and the new treatment regimen prescribed, if applicable, will be documented. The next routine follow-up visit will be the termination visit for this patient in the PMOS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population consists of adult patients in Eastern European countries with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) who can be administered Humira as per locally approved label.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult patients with active RA, PsA or AS for whom Humira therapy is indicated according to the local product label and who meet the following criteria:\n\n* Are newly prescribed Humira therapy (no prior history of treatment with Humira), including patients with infliximab or etanercept treatment history OR\n* Completed Abbott sponsored interventional clinical trials and are continuing treatment with commercial Humira 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