Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT00195494
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
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': 'D000068800', 'term': 'Etanercept'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintrialresults@wyeth.com', 'title': 'U. S. Contact Center', 'organization': 'Wyeth'}, 'certainAgreement': {'otherDetails': 'The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Year 1 E+M / Year 2 E+M', 'description': 'Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).\n\nDose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.', 'otherNumAffected': 91, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Year 1 M / Year 2 E+M', 'description': 'Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).\n\nDose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.', 'otherNumAffected': 71, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Year 1 E+M / Year 2 E', 'description': 'Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).', 'otherNumAffected': 89, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Year 1 M / Year 2 M', 'description': 'Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).\n\nNo reduction of MTX dose is permitted in year two.', 'otherNumAffected': 79, 'seriousNumAffected': 12}, {'id': 'EG004', 'title': 'Year 1 M+Placebo', 'description': 'Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.', 'otherNumAffected': 241, 'seriousNumAffected': 34}, {'id': 'EG005', 'title': 'Year 1 E+M', 'description': 'Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.', 'otherNumAffected': 246, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Blood and lymphatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear and labyrinth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 11}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 28}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarhhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 48}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 50}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 50}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 49}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 36}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aterial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 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'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Spondylolisthesis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant melanoma of sights other than skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Testicular torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 1 M', 'description': 'Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.'}, {'id': 'OG001', 'title': 'Year 1 E+M', 'description': 'etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '22.0', 'estimateComment': 'E+M (49.8%) - M (27.8%) creates the risk difference estimated value.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.', 'anticipatedPostingDate': '2009-03'}, {'type': 'PRIMARY', 'title': 'Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 1 M', 'description': 'Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.'}, {'id': 'OG001', 'title': 'Year 1 E+M', 'description': 'etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'paramValue': '21.0', 'estimateComment': 'E+M (79.7%) - M (58.7%) creates the risk difference estimated value.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.', 'anticipatedPostingDate': '2009-03'}, {'type': 'SECONDARY', 'title': 'Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}, {'value': '268', 'groupId': 'OG004'}, {'value': '274', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 2 E+M / E+M', 'description': 'Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).\n\nDose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.'}, {'id': 'OG001', 'title': 'Year 2 M / E+M', 'description': 'Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).\n\nDose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.'}, {'id': 'OG002', 'title': 'Year 2 E+M / E', 'description': 'Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).'}, {'id': 'OG003', 'title': 'Year 2 M / M', 'description': 'Following a blinded transition from year one- MTX dose consistent with the ending dose of year one (usually 20 mgs).\n\nNo reduction of MTX dose is permitted in year two.'}, {'id': 'OG004', 'title': 'Year 1 M+Placebo', 'description': 'Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.'}, {'id': 'OG005', 'title': 'Year 1 E+M', 'description': 'Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24 months', 'description': 'Safety report for entire trial where participants reported a serious adverse event that led to death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the modified intent to treat for year 1 (542 overall baseline participants) and year 2 (411 overall baseline participants).', 'anticipatedPostingDate': '2009-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Year 1 E+M / Year 2 E+M', 'description': 'Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).\n\nDose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.'}, {'id': 'FG001', 'title': 'Year 1 M / Year 2 E+M', 'description': 'Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).\n\nDose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.'}, {'id': 'FG002', 'title': 'Year 1 E+M / Year 2 E', 'description': 'Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).'}, {'id': 'FG003', 'title': 'Year 1 M / Year 2 M', 'description': 'Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).\n\nNo reduction of MTX dose is permitted in year two.'}, {'id': 'FG004', 'title': 'Year 1 M+Placebo', 'description': 'Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.'}, {'id': 'FG005', 'title': 'Year 1 E+M', 'description': 'Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.'}], 'periods': [{'title': 'Year 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '268'}, {'groupId': 'FG005', 'numSubjects': '274'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '189'}, {'groupId': 'FG005', 'numSubjects': '221'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '79'}, {'groupId': 'FG005', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '27'}]}, {'type': 'System Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Missed >4 consecutive doses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Year 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A patient with Year 1 termination had taken drug briefly during Year 2 and thus counted in the data.', 'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'comment': 'A patient with Year 1 termination had taken drug briefly during Year 2 and thus counted in the data.', 'groupId': 'FG002', 'numSubjects': '111'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '76'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Missed >4 consecutive doses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'System toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited worldwide from November 2004 to February 2006.', 'preAssignmentDetails': 'Participants were randomly assigned equally to 1 of 4 blinded treatment groups: Group (G) 1a received the combination of etanercept (E) and methotrexate (M) in year Y1 and Y2. G1b received the combination of E and M in Y1 and E alone in Y2. G2a received M alone in Y1 and the combination of E and M in Y2. G2b received M alone in Y1 and Y2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '542', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Year 1 M+Placebo', 'description': 'Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.'}, {'id': 'BG001', 'title': 'Year 1 E+M', 'description': 'Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).\n\nMTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.50', 'groupId': 'BG000', 'lowerLimit': '20.00', 'upperLimit': '84.00'}, {'value': '52.50', 'groupId': 'BG001', 'lowerLimit': '18.00', 'upperLimit': '82.00'}, {'value': '52.00', 'groupId': 'BG002', 'lowerLimit': '18.00', 'upperLimit': '84.00'}]}]}], 'paramType': 'MEDIAN', 'description': 'Year 1 Overall Number of Baseline Participants is 542', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Year 1 participants collected from Arms M and E+M equal the stated overall participant population of 542. 411 of those participants were then entered into Year 2 Arms E+M/E+M, M/M+E, E+M/E, M/M. This measure provides the gender population for Year 1 only in order to accurately reflect the overall baseline population of 542.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 542}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-01', 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.', 'timeFrame': '12 months', 'description': 'Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.'}, {'measure': 'Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.', 'timeFrame': '12 months', 'description': 'The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.'}], 'secondaryOutcomes': [{'measure': 'Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death', 'timeFrame': '12 and 24 months', 'description': 'Safety report for entire trial where participants reported a serious adverse event that led to death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '28255449', 'type': 'DERIVED', 'citation': 'Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.'}, {'pmid': '27175292', 'type': 'DERIVED', 'citation': 'Gallo G, Brock F, Kerkmann U, Kola B, Huizinga TW. Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage. RMD Open. 2016 Apr 21;2(1):e000186. doi: 10.1136/rmdopen-2015-000186. eCollection 2016.'}, {'pmid': '21719418', 'type': 'DERIVED', 'citation': 'Zhang W, Sun H, Emery P, Sato R, Singh A, Freundlich B, Anis AH. Does achieving clinical response prevent work stoppage or work absence among employed patients with early rheumatoid arthritis? Rheumatology (Oxford). 2012 Feb;51(2):270-4. doi: 10.1093/rheumatology/ker189. Epub 2011 Jun 29.'}, {'pmid': '18635256', 'type': 'DERIVED', 'citation': 'Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, Singh A, Pedersen RD, Koenig AS, Freundlich B. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008 Aug 2;372(9636):375-82. doi: 10.1016/S0140-6736(08)61000-4. Epub 2008 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis\n* Has RA greater than or equal to 3 months and less than or equal to 2 years\n\nExclusion Criteria:\n\n* Received any previous treatment with MTX\n* Received any previous treatment with ETN or other tumour necrosis factor antagonist'}, 'identificationModule': {'nctId': 'NCT00195494', 'briefTitle': 'Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '0881A-101548'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1a', 'description': 'Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)', 'interventionNames': ['Drug: Etanercept', 'Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1b', 'description': 'Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)', 'interventionNames': ['Drug: Etanercept', 'Drug: Methotrexate', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2a', 'description': 'Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)', 'interventionNames': ['Drug: Etanercept', 'Drug: Methotrexate', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2b', 'description': 'Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'description': 'Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 \\& 2\n\nGroup 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2\n\nGroup 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2', 'armGroupLabels': ['1a', '1b', '2a']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 \\& 2\n\nGroup 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2\n\nGroup 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2\n\nGroup 2b: Oral Methotrexate weekly for both Periods 1 and 2', 'armGroupLabels': ['1a', '1b', '2a', '2b']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2\n\nGroup 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2', 'armGroupLabels': ['1b', '2a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}