Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00796705
Status:
TERMINATED
Last Update Posted:
2012-10-04
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DAITClinicalTrialsGov@niaid.nih.gov', 'phone': '301-594-7669', 'title': 'Associate Director, Clinical Research Operations Program', 'organization': 'DAIT/NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study terminated early due to recruitment feasibility issues. Thirteen subjects were enrolled and received treatment. No mechanistic analyses were performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Non-Switcher/Adalimumab', 'description': 'Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Subjects failing Etanercept at screening who were randomized to remain on Etanercept', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Subjects failing Adalimumab at screening who were randomized to switch to Etanercept', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Switcher/Etanercept to Adalimumab', 'description': 'Subjects failing Etanercept at screening who were randomized to switch to Adalimumab', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gallop rhythm present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Prolonged expiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/ Adalimumab or Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion and participants defined as etanercept failures \\[2\\] at screening who were randomized to receive etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n1. Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.\n2. Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG001', 'title': 'Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion and participants defined as etanercept failures \\[2\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg SQ injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n1. Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.\n2. Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'PRIMARY', 'title': 'Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '1.81', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28\\[CRP\\] value of ≥ 1.2.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Participants With an ACR 20 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP)", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Participants With an ACR 50 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP)", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Participants With an ACR 70 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'OG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'OG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP)", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'FG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'FG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'FG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject recruitment occurred between November 2008 and November 2010 at 16 sites located in the United States. All sites utilized a rheumatology clinic and outside referrals for recruitment.', 'preAssignmentDetails': 'Each subject signed an informed consent prior to undergoing any screening procedures. At the screening visit, subjects underwent procedures to establish inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-Switcher/Adalimumab Alternating With Placebo', 'description': 'Participants defined as adalimumab failures \\[1\\] at screening who were randomized to remain on adalimumab (one 40 milligram \\[mg\\] subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 millilitre \\[mL\\] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'BG001', 'title': 'Non-Switcher/Etanercept', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'BG002', 'title': 'Switcher/Adalimumab to Etanercept', 'description': 'Participants defined as adalimumab failures \\[1\\]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.\n\n\\[1\\] Adalimumab failures: participants with rheumatoid arthritis \\[RA\\] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.'}, {'id': 'BG003', 'title': 'Switcher/Etanercept to Adalimumab Alternating With Placebo', 'description': 'Participants defined as etanercept failures \\[1\\] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous \\[SQ\\] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.\n\n\\[1\\] Etanercept failures: participants with rheumatoid arthritis \\[RA\\] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '65', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '39', 'spread': '13.7', 'groupId': 'BG002'}, {'value': '60', 'spread': '6.4', 'groupId': 'BG003'}, {'value': '53', 'spread': '14.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Activity Score Using C-reactive Protein (DAS28[CRP])', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.66', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '0.44', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '0.62', 'groupId': 'BG002'}, {'value': '5.3', 'spread': '0.19', 'groupId': 'BG003'}, {'value': '5.3', 'spread': '0.56', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The DAS28 is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Lack of Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-28', 'studyFirstSubmitDate': '2008-11-20', 'resultsFirstSubmitDate': '2012-07-05', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-05', 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.', 'timeFrame': 'Baseline, Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).'}, {'measure': 'Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.', 'timeFrame': 'Baseline, Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).'}], 'secondaryOutcomes': [{'measure': 'Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12', 'timeFrame': 'Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).'}, {'measure': 'Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12', 'timeFrame': 'Week 12', 'description': 'The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).'}, {'measure': 'Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)', 'timeFrame': 'Baseline, Week 12', 'description': 'The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28\\[CRP\\] value of ≥ 1.2.'}, {'measure': 'Participants With an ACR 20 Response at Week 12', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP)"}, {'measure': 'Participants With an ACR 50 Response at Week 12', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP)"}, {'measure': 'Participants With an ACR 70 Response at Week 12', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP)"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '20386564', 'type': 'BACKGROUND', 'citation': 'Villeneuve E, Haraoui B. To switch or to change class-the biologic dilemma in rheumatoid arthritis. Nat Rev Rheumatol. 2010 May;6(5):301-5. doi: 10.1038/nrrheum.2010.45. Epub 2010 Apr 13.'}, {'pmid': '19368701', 'type': 'BACKGROUND', 'citation': 'Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009;11 Suppl 1(Suppl 1):S1. doi: 10.1186/ar2666. Epub 2009 Apr 6.'}, {'pmid': '9778226', 'type': 'BACKGROUND', 'citation': 'van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845-50. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-K.'}]}, 'descriptionModule': {'briefSummary': 'Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.', 'detailedDescription': 'Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor Necrosis Factor (TNF) alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness of switching to an alternative TNF-alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA who have had inadequate clinical response to the study drugs etanercept and adalimumab.\n\nThis study will last approximately 16 weeks. Participants will be randomized into two arms and receive injections once per week for 12 weeks. Participants in the adalimumab arm will receive alternating subcutaneous adalimumab and adalimumab placebo injections. Participants in the etanercept arm will receive subcutaneous etanercept injections.\n\nThis study consists of thirteen study visits after randomization. Study visits will occur on a weekly basis for 12 weeks prior to a follow-up visit at Week 16. A vital signs measurement and adverse event assessment will occur at each visit. A physical exam, assessment of tender and swollen joints, medication assessment, and blood collection will occur at Weeks 4, 8, 12, and 16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Rheumatoid Arthritis\n* Current treatment with either etanercept or adalimumab for at least 12 weeks prior to randomization\n* Disease Activity Score (DAS) C-reactive Protein (CRP) 28 ≥ 4.4\n* Treatment with concomitant Disease-Modifying Anti-Rheumatic Drugs (DMARDs) is permitted but not required as described below:\n\n 1. Methotrexate - maximum dose of 25 mg per os (PO), intra-muscular (IM), or SQ weekly.\n 2. Leflunomide - maximum dose of 20 mg PO daily.\n 3. Sulfasalazine - maximum dose of 1,500 mg PO twice daily.\n 4. Hydroxychloroquine - maximum dose of 400 mg PO daily.\n* If taking DMARD(s), subjects must be on stable doses for at least 12 weeks prior to randomization.\n* If treated with prednisone (or equivalent corticosteroid), on a stable dose of \\<= 10 mg/day for 28 days prior to randomization.\n* Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.\n\nExclusion Criteria:\n\n* Diagnosis of another autoimmune disease likely to require immunosuppression. More information on this criterion can be found in the protocol.\n* Failing treatment with etanercept if previously treated with adalimumab\n* Failing treatment with adalimumab if previously treated with etanercept\n* Intraarticular injection within 4 weeks prior to randomization\n* Concomitant use of DMARDs other than those described in Inclusion Criteria within 12 weeks of randomization.\n* Concurrent use of any biologic agent other than etanercept or adalimumab\n* Concomitant immunosuppressive therapy other than the Disease-Modifying Anti-Rheumatic Drugs (DMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), or corticosteroids specified in the protocol\n* Presence of open leg ulcers\n* Chronic or persistent infection that may be worsened by immunosuppressive treatment. More information on this criterion can be found in the protocol.\n* Active infection or severe infections requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 30 days prior to randomization\n* History of positive Purified Protein Derivative (PPD) or chest x-ray findings indicative of prior tuberculosis infection\n* Any medical condition or treatment that, in the opinion of the investigator, would put the subject at risk by participation in the study\n* History of malignancy. More information on this criterion can be found in the protocol.\n* Certain abnormal laboratory values. More information on this criterion can be found in the protocol.\n* Investigational biological or chemical agents within 4 weeks prior to randomization.\n* History of drug or alcohol abuse within a year prior to randomization\n* Treatment with natalizumab, rituximab, or another B-cell depleting therapy within a year prior to randomization\n* Treatment with infliximab, abatacept, tocilizumab, golimumab, or certolizumab pegol within 12 weeks prior to randomization.\n* Known allergy or hypersensitivity to study products\n* Any psychiatric disorder that prevents the participant from providing informed consent\n* Inability to follow protocol instructions\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00796705', 'briefTitle': 'Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition', 'orgStudyIdInfo': {'id': 'DAIT ARA05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adalimumab / Adalimumab Placebo', 'description': '1 sub-cutaneous (SQ) injection of adalimumab or 1 SQ injection of placebo will be given in a blinded and alternating fashion for a total of 12 weeks', 'interventionNames': ['Drug: Adalimumab', 'Drug: Adalimumab placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Etanercept', 'description': 'Participants will receive 1 SQ injection of etanercept each week for 12 weeks', 'interventionNames': ['Drug: Etanercept']}], 'interventions': [{'name': 'Adalimumab', 'type': 'DRUG', 'otherNames': ['Humira'], 'description': '40 mg injection of adalimumab administered subcutaneously', 'armGroupLabels': ['Adalimumab / Adalimumab Placebo']}, {'name': 'Adalimumab placebo', 'type': 'DRUG', 'otherNames': ['Humira placebo'], 'description': '1.0 ml .9% saline placebo administered subcutaneously', 'armGroupLabels': ['Adalimumab / Adalimumab Placebo']}, {'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': '50 mg dimeric fusion protein administered subcutaneously', 'armGroupLabels': ['Etanercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Arthritis Research Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Medical Group', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Justus Fiechtner, MD, PC', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '14642', 'city': 'Manhassett', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institute for Medical Research NS-LIJ'}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Bone and Joint', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Medical Research Foundation', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Larry Moreland, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Mark Genovese, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}