Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-01 @ 2:11 PM
Study NCT ID:
NCT01578850
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Saudi Arabia']}, '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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events were reported from the signing of the informed consent to 28 days after the last dose of study medication through the last participant's visit.", 'description': 'The Open Label Safety Population is defined as all participants who had at least one dose of open label study drug during Period 1. The Double Blind Safety Population is defined as all randomized participants who had at least one dose of study drug during period 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg with MTX (with or without other DMARDs).', 'otherNumAtRisk': 489, 'otherNumAffected': 26, 'seriousNumAtRisk': 489, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).', 'otherNumAtRisk': 167, 'otherNumAffected': 4, 'seriousNumAtRisk': 167, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).', 'otherNumAtRisk': 176, 'otherNumAffected': 9, 'seriousNumAtRisk': 176, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Salmonella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 489, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.3', 'ciLowerLimit': '16.78', 'ciUpperLimit': '35.81', 'estimateComment': 'Participants who took rescue therapy had the final value taken before rescue used for analysis at all ensuing time points.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 52', 'description': 'Proportion of participants who remained in LDA DAS28-ESR \\<3.2 at Week 52 is presented below.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.7', 'ciLowerLimit': '6.83', 'ciUpperLimit': '40.61', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The p-value from CMH test of general association was stratified by geographic region.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 52', 'description': 'Proportion of participants who remained in Remission (DAS28-ESR \\<2.6) at Week 52.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'DAS28-ESR Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'DAS28-ESR Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000'}, {'value': '85.1', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000'}, {'value': '55.4', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '24.4', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000'}, {'value': '41.9', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000'}, {'value': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '37.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.371', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '0.57', 'groupDescription': 'DAS28-ESR Baseline', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '1.81', 'groupDescription': 'DAS28-CRP Baseline', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.667', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-4.76', 'ciUpperLimit': '9.98', 'groupDescription': 'DAS28-CRP Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.5', 'ciLowerLimit': '10.99', 'ciUpperLimit': '32.02', 'groupDescription': 'DAS28-ESR Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.0', 'ciLowerLimit': '8.81', 'ciUpperLimit': '29.10', 'groupDescription': 'DAS28-CRP Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.8', 'ciLowerLimit': '20.79', 'ciUpperLimit': '40.83', 'groupDescription': 'DAS28-ESR Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '16.89', 'ciUpperLimit': '37.54', 'groupDescription': 'DAS28-CRP Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.3', 'ciLowerLimit': '21.51', 'ciUpperLimit': '41.08', 'groupDescription': 'DAS28-ESR Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.2', 'ciLowerLimit': '19.95', 'ciUpperLimit': '40.47', 'groupDescription': 'DAS28-CRP Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.3', 'ciLowerLimit': '16.78', 'ciUpperLimit': '35.81', 'groupDescription': 'DAS28-ESR Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.1', 'ciLowerLimit': '16.67', 'ciUpperLimit': '37.47', 'groupDescription': 'DAS28-CRP Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'DAS28-ESR Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'DAS28-ESR Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000'}, {'value': '63.1', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000'}, {'value': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}, {'value': '34.9', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '25.1', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.774', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-9.03', 'ciUpperLimit': '11.68', 'groupDescription': 'DAS28-CRP Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.3', 'ciLowerLimit': '2.86', 'ciUpperLimit': '21.69', 'groupDescription': 'DAS28-ESR Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.9', 'ciLowerLimit': '6.33', 'ciUpperLimit': '27.54', 'groupDescription': 'DAS28-CRP Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.6', 'ciLowerLimit': '5.48', 'ciUpperLimit': '23.80', 'groupDescription': 'DAS28-ESR Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.9', 'ciLowerLimit': '14.72', 'ciUpperLimit': '34.98', 'groupDescription': 'DAS28-CRP Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.8', 'ciLowerLimit': '10.16', 'ciUpperLimit': '27.38', 'groupDescription': 'DAS28-ESR Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.9', 'ciLowerLimit': '21.03', 'ciUpperLimit': '40.76', 'groupDescription': 'DAS28-CRP Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.6', 'ciLowerLimit': '11.78', 'ciUpperLimit': '29.52', 'groupDescription': 'DAS28-ESR Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '17.38', 'ciUpperLimit': '36.93', 'groupDescription': 'DAS28-CRP Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'DAS28-ESR Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '-1.61', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '-1.61', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '-2.09', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '-2.62', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '-2.54', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-ESR Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '-3.23', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'DAS28-CRP Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '-2.95', 'spread': '1.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'DAS28-ESR Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-3.79', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-3.36', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-3.32', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-3.35', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-2.73', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '-3.06', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-3.20', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-2.40', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-2.97', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-2.27', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-3.15', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-2.31', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-2.95', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-3.08', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-2.92', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-2.16', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '-0.20', 'groupDescription': 'DAS28-ESR Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.11', 'groupDescription': 'DAS28-CRP Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '-0.39', 'groupDescription': 'DAS28-ESR Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.28', 'groupDescription': 'DAS28-CRP Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.46', 'groupDescription': 'DAS28-ESR Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.37', 'groupDescription': 'DAS28-CRP Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '-0.40', 'groupDescription': 'DAS28-ESR Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.36', 'groupDescription': 'DAS28-CRP Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000'}, {'value': '79.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 52', 'description': 'Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'Good Response: DAS28-ESR Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Good Response: DAS28-CRP Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}]}]}, {'title': 'Good Response: DAS28-ESR Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}]}]}, {'title': 'Good Response: DAS28-CRP Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000'}]}]}, {'title': 'Good Response: DAS28-ESR Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}]}]}, {'title': 'Good Response: DAS28-CRP Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}]}]}, {'title': 'Good Response: DAS28-ESR Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000'}]}]}, {'title': 'Good Response: DAS28-CRP Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (\\>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'Good Response: DAS28-ESR Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}, {'value': '99.4', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-CRP Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}, {'value': '85.1', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-ESR Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000'}, {'value': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-CRP Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}, {'value': '54.8', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-ESR Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-CRP Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '67.9', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-ESR Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-CRP Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}, {'value': '37.7', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-ESR Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Good Response: DAS28-CRP Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '90.4', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000'}, {'value': '83.9', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '85.6', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '81.5', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-ESR Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response: DAS28-CRP Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-6.13', 'ciUpperLimit': '8.90', 'groupDescription': 'Good Response: DAS28-CRP Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.5', 'ciLowerLimit': '10.99', 'ciUpperLimit': '32.02', 'groupDescription': 'Good Response: DAS28-ESR Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '8.08', 'ciUpperLimit': '28.53', 'groupDescription': 'Good Response: DAS28-CRP Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.4', 'ciLowerLimit': '21.42', 'ciUpperLimit': '41.39', 'groupDescription': 'Good Response: DAS28-ESR Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '16.83', 'ciUpperLimit': '37.54', 'groupDescription': 'Good Response: DAS28-CRP Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.3', 'ciLowerLimit': '21.53', 'ciUpperLimit': '41.02', 'groupDescription': 'Good Response: DAS28-ESR Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.8', 'ciLowerLimit': '20.54', 'ciUpperLimit': '41.05', 'groupDescription': 'Good Response: DAS28-CRP Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.3', 'ciLowerLimit': '16.82', 'ciUpperLimit': '35.74', 'groupDescription': 'Good Response: DAS28-ESR Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.0', 'ciLowerLimit': '16.63', 'ciUpperLimit': '37.44', 'groupDescription': 'Good Response: DAS28-CRP Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.766', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '1.65', 'groupDescription': 'Good Response: DAS28-ESR Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '2.32', 'ciUpperLimit': '14.10', 'groupDescription': 'Moderate Response: DAS28-ESR Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '1.28', 'ciUpperLimit': '11.75', 'groupDescription': 'Moderate Response: DAS28-CRP Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.9', 'ciLowerLimit': '3.27', 'ciUpperLimit': '16.60', 'groupDescription': 'Moderate Response: DAS28-ESR Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '2.43', 'ciUpperLimit': '15.20', 'groupDescription': 'Moderate Response: DAS28-CRP Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '4.69', 'ciUpperLimit': '18.72', 'groupDescription': 'Moderate Response: DAS28-ESR Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.6', 'ciLowerLimit': '4.20', 'ciUpperLimit': '17.06', 'groupDescription': 'Moderate Response: DAS28-ESR Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '4.15', 'ciUpperLimit': '18.06', 'groupDescription': 'Moderate Response: DAS28-ESR Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.2', 'ciLowerLimit': '4.92', 'ciUpperLimit': '17.58', 'groupDescription': 'Moderate Response: DAS28-CRP Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (\\>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'CDAI: LDA Baseline (N= 478)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: LDA Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: LDA Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: LDA Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: LDA Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: Remission: Baseline (N= 478)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: Remission: Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: Remission: Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: Remission: Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'CDAI: Remission: Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: LDA: Baseline (N= 478)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: LDA: Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: LDA: Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: LDA: Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: LDA: Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: Remission: Baseline (N= 478)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: Remission: Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: Remission: Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: Remission: Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'SDAI: Remission: Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'CDAI: LDA Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: LDA Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000'}, {'value': '90.5', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: LDA Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000'}, {'value': '57.7', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: LDA Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}, {'value': '47.0', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: LDA Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: LDA Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Remission: Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Remission: Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Remission: Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Remission: Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Remission: Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Remission: Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: LDA: Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: LDA: Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}, {'value': '86.9', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: LDA: Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}, {'value': '55.4', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: LDA: Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '42.5', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: LDA: Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '42.5', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: LDA: Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '37.7', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Remission: Baseline (N= 163, 168)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Remission: Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Remission: Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Remission: Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Remission: Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Remission: Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '1.81', 'groupDescription': 'CDAI: LDA Baseline', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-2.38', 'ciUpperLimit': '9.16', 'groupDescription': 'CDAI: LDA: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '8.40', 'ciUpperLimit': '28.27', 'groupDescription': 'CDAI: LDA: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.1', 'ciLowerLimit': '13.88', 'ciUpperLimit': '34.40', 'groupDescription': 'CDAI: LDA: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.1', 'ciLowerLimit': '16.85', 'ciUpperLimit': '37.35', 'groupDescription': 'CDAI: LDA: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.0', 'ciLowerLimit': '13.61', 'ciUpperLimit': '34.42', 'groupDescription': 'CDAI: LDA: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.774', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-5.50', 'ciUpperLimit': '10.06', 'groupDescription': 'CDAI: Remission: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.645', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-7.15', 'ciUpperLimit': '8.03', 'groupDescription': 'CDAI: Remission: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '0.36', 'ciUpperLimit': '16.35', 'groupDescription': 'CDAI: Remission: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '1.49', 'ciUpperLimit': '17.68', 'groupDescription': 'CDAI: Remission: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '1.02', 'ciUpperLimit': '16.88', 'groupDescription': 'CDAI: Remission: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '1.81', 'groupDescription': 'SDAI: LDA: Baseline', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.258', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-3.57', 'ciUpperLimit': '10.13', 'groupDescription': 'SDAI: LDA: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.7', 'ciLowerLimit': '7.49', 'ciUpperLimit': '27.92', 'groupDescription': 'SDAI: LDA: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '16.93', 'ciUpperLimit': '37.55', 'groupDescription': 'SDAI: LDA: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.0', 'ciLowerLimit': '21.83', 'ciUpperLimit': '42.23', 'groupDescription': 'SDAI: LDA: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.3', 'ciLowerLimit': '18.00', 'ciUpperLimit': '38.69', 'groupDescription': 'SDAI: LDA: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-5.51', 'ciUpperLimit': '11.51', 'groupDescription': 'SDAI: Remission: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-8.03', 'ciUpperLimit': '8.00', 'groupDescription': 'SDAI: Remission: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.3', 'ciLowerLimit': '2.07', 'ciUpperLimit': '18.45', 'groupDescription': 'SDAI: Remission: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '0.85', 'ciUpperLimit': '17.25', 'groupDescription': 'SDAI: Remission: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.1', 'ciLowerLimit': '3.70', 'ciUpperLimit': '20.57', 'groupDescription': 'SDAI: Remission: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization'}, {'type': 'SECONDARY', 'title': 'Change of CDAI and SDAI at Each Visit During Period 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'CDAI Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '-16.78', 'spread': '11.72', 'groupId': 'OG000'}]}]}, {'title': 'CDAI Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '-21.69', 'spread': '12.40', 'groupId': 'OG000'}]}]}, {'title': 'CDAI Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '-25.77', 'spread': '13.19', 'groupId': 'OG000'}]}]}, {'title': 'CDAI Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '-29.25', 'spread': '13.66', 'groupId': 'OG000'}]}]}, {'title': 'SDAI Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '-18.19', 'spread': '12.44', 'groupId': 'OG000'}]}]}, {'title': 'SDAI Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '-23.06', 'spread': '12.89', 'groupId': 'OG000'}]}]}, {'title': 'SDAI Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '-27.17', 'spread': '13.61', 'groupId': 'OG000'}]}]}, {'title': 'SDAI Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '-30.56', 'spread': '14.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change of CDAI and SDAI at Each Visit During Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'CDAI: Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-32.11', 'spread': '12.06', 'groupId': 'OG000'}, {'value': '-32.23', 'spread': '12.49', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-29.62', 'spread': '13.10', 'groupId': 'OG000'}, {'value': '-26.49', 'spread': '15.87', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-28.71', 'spread': '13.56', 'groupId': 'OG000'}, {'value': '-24.33', 'spread': '16.45', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-28.63', 'spread': '13.58', 'groupId': 'OG000'}, {'value': '-23.81', 'spread': '16.48', 'groupId': 'OG001'}]}]}, {'title': 'CDAI: Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-28.30', 'spread': '13.61', 'groupId': 'OG000'}, {'value': '-23.52', 'spread': '15.98', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-33.61', 'spread': '12.07', 'groupId': 'OG000'}, {'value': '-33.68', 'spread': '13.03', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '-31.07', 'spread': '13.58', 'groupId': 'OG000'}, {'value': '-27.58', 'spread': '16.50', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-30.20', 'spread': '14.05', 'groupId': 'OG000'}, {'value': '-25.44', 'spread': '17.17', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-30.21', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '-24.85', 'spread': '17.29', 'groupId': 'OG001'}]}]}, {'title': 'SDAI: Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-29.86', 'spread': '14.03', 'groupId': 'OG000'}, {'value': '-24.57', 'spread': '16.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-4.19', 'ciUpperLimit': '-0.01', 'groupDescription': 'CDAI: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.38', 'ciLowerLimit': '-5.72', 'ciUpperLimit': '-1.05', 'groupDescription': 'CDAI: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.02', 'ciLowerLimit': '-6.37', 'ciUpperLimit': '-1.67', 'groupDescription': 'CDAI: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.02', 'ciLowerLimit': '-6.36', 'ciUpperLimit': '-1.68', 'groupDescription': 'CDAI: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.22', 'ciLowerLimit': '-4.40', 'ciUpperLimit': '-0.03', 'groupDescription': 'SDAI: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.54', 'ciLowerLimit': '-5.97', 'ciUpperLimit': '-1.12', 'groupDescription': 'SDAI: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.33', 'ciLowerLimit': '-6.78', 'ciUpperLimit': '-1.88', 'groupDescription': 'SDAI: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.27', 'ciLowerLimit': '-6.70', 'ciUpperLimit': '-1.84', 'groupDescription': 'SDAI: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'ACR 20: Week 4 (N= 469)', 'categories': [{'measurements': [{'value': '58.6', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'ACR 20: Week 8 (N= 469)', 'categories': [{'measurements': [{'value': '73.1', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'ACR 20: Week 16 (N= 469)', 'categories': [{'measurements': [{'value': '83.6', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'ACR 20: Week 24 (N= 469)', 'categories': [{'measurements': [{'value': '87.8', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'ACR 50: Week 4 (N= 469)', 'categories': [{'measurements': [{'value': '19.8', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'ACR 50: Week 8 (N= 469)', 'categories': [{'measurements': [{'value': '35.8', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'ACR 50: Week 16 (N= 469)', 'categories': [{'measurements': [{'value': '55.2', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'ACR 50: Week 24 (N= 469)', 'categories': [{'measurements': [{'value': '72.5', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'ACR 70: Week 4 (N= 469)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'ACR 70: Week 8 (N= 469)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'ACR 70: Week 16 (N= 469)', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'ACR 70: Week 24 (N= 469)', 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}]}]}, {'title': 'ACR 90: Week 4 (N= 469)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'ACR 90: Week 8 (N= 469)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'ACR 90: Week 16 (N= 469)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'ACR 90: Week 24 (N= 469)', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'ACR 20: Week 24 (N= 161, 168)', 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000'}, {'value': '96.4', 'groupId': 'OG001'}]}]}, {'title': 'ACR 20: Week 28 (N= 161, 168)', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000'}, {'value': '81.5', 'groupId': 'OG001'}]}]}, {'title': 'ACR 20: Week 36 (N= 161, 168)', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '76.8', 'groupId': 'OG001'}]}]}, {'title': 'ACR 20: Week 44 (N= 161, 168)', 'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000'}, {'value': '76.2', 'groupId': 'OG001'}]}]}, {'title': 'ACR 20: Week 52 (N= 161, 168)', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000'}, {'value': '76.2', 'groupId': 'OG001'}]}]}, {'title': 'ACR 50: Week 24 (N= 161, 168)', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}]}]}, {'title': 'ACR 50: Week 28 (N= 161, 168)', 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000'}, {'value': '63.7', 'groupId': 'OG001'}]}]}, {'title': 'ACR 50: Week 36 (N= 161, 168)', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}]}]}, {'title': 'ACR 50: Week 44 (N= 161, 168)', 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}]}]}, {'title': 'ACR 50: Week 52 (N= 161, 168)', 'categories': [{'measurements': [{'value': '68.3', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}]}]}, {'title': 'ACR 70: Week 24 (N= 161, 168)', 'categories': [{'measurements': [{'value': '49.7', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}]}]}, {'title': 'ACR 70: Week 28 (N= 161, 168)', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}]}]}, {'title': 'ACR 70: Week 36 (N= 161, 168)', 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}, {'value': '27.4', 'groupId': 'OG001'}]}]}, {'title': 'ACR 70: Week 44 (N= 161, 168)', 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'ACR 70: Week 52 (N= 161, 168)', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'ACR 90: Week 24 (N= 161, 168)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'ACR 90: Week 28 (N= 161, 168)', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'ACR 90: Week 36 (N= 161, 168)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'ACR 90: Week 44 (N= 161, 168)', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'ACR 90: Week 52 (N= 161, 168)', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.742', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-4.21', 'ciUpperLimit': '3.90', 'groupDescription': 'ACR 20: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '2.45', 'ciUpperLimit': '17.06', 'groupDescription': 'ACR 20: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '3.31', 'ciUpperLimit': '19.51', 'groupDescription': 'ACR 20: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.1', 'ciLowerLimit': '1.80', 'ciUpperLimit': '18.49', 'groupDescription': 'ACR 20: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '2.49', 'ciUpperLimit': '19.05', 'groupDescription': 'ACR 20: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.584', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '9.75', 'groupDescription': 'ACR 50: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.5', 'ciLowerLimit': '1.59', 'ciUpperLimit': '21.34', 'groupDescription': 'ACR 50: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.2', 'ciLowerLimit': '6.76', 'ciUpperLimit': '27.56', 'groupDescription': 'ACR 50: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.0', 'ciLowerLimit': '8.59', 'ciUpperLimit': '29.35', 'groupDescription': 'ACR 50: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.7', 'ciLowerLimit': '7.30', 'ciUpperLimit': '28.16', 'groupDescription': 'ACR 50: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.702', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-13.49', 'ciUpperLimit': '8.11', 'groupDescription': 'ACR 70: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.378', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '-3.37', 'ciUpperLimit': '17.50', 'groupDescription': 'ACR 70: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.3', 'ciLowerLimit': '7.12', 'ciUpperLimit': '27.56', 'groupDescription': 'ACR 70: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.5', 'ciLowerLimit': '8.40', 'ciUpperLimit': '28.55', 'groupDescription': 'ACR 70: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.0', 'ciLowerLimit': '5.96', 'ciUpperLimit': '26.02', 'groupDescription': 'ACR 70: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-6.19', 'ciUpperLimit': '5.67', 'groupDescription': 'ACR 90: Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-2.19', 'ciUpperLimit': '8.86', 'groupDescription': 'ACR 90: Week 28', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '0.41', 'ciUpperLimit': '12.48', 'groupDescription': 'ACR 90: Week 36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '10.08', 'groupDescription': 'ACR 90: Week 44', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '12.40', 'groupDescription': 'ACR 90: Week 52', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': '28 Tender Joint Count: Week 4', 'categories': [{'measurements': [{'value': '-6.49', 'spread': '6.07', 'groupId': 'OG000'}]}]}, {'title': '28 Tender Joint Count: Week 8', 'categories': [{'measurements': [{'value': '-8.59', 'spread': '6.32', 'groupId': 'OG000'}]}]}, {'title': '28 Tender Joint Count: Week 16', 'categories': [{'measurements': [{'value': '-10.12', 'spread': '6.82', 'groupId': 'OG000'}]}]}, {'title': '28 Tender Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-11.50', 'spread': '6.79', 'groupId': 'OG000'}]}]}, {'title': '28 Swollen Joint Count: Week 4', 'categories': [{'measurements': [{'value': '-5.52', 'spread': '5.02', 'groupId': 'OG000'}]}]}, {'title': '28 Swollen Joint Count: Week 8', 'categories': [{'measurements': [{'value': '-7.04', 'spread': '5.36', 'groupId': 'OG000'}]}]}, {'title': '28 Swollen Joint Count: Week 16', 'categories': [{'measurements': [{'value': '-8.21', 'spread': '5.44', 'groupId': 'OG000'}]}]}, {'title': '28 Swollen Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-9.01', 'spread': '5.65', 'groupId': 'OG000'}]}]}, {'title': '68 Tender Joint Count: Week 4', 'categories': [{'measurements': [{'value': '-9.71', 'spread': '10.00', 'groupId': 'OG000'}]}]}, {'title': '68 Tender Joint Count: Week 8', 'categories': [{'measurements': [{'value': '-13.02', 'spread': '10.95', 'groupId': 'OG000'}]}]}, {'title': '68 Tender Joint Count: Week 16', 'categories': [{'measurements': [{'value': '-15.21', 'spread': '11.90', 'groupId': 'OG000'}]}]}, {'title': '68 Tender Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-17.41', 'spread': '12.72', 'groupId': 'OG000'}]}]}, {'title': '68 Swollen Joint Count: Week 4', 'categories': [{'measurements': [{'value': '-7.12', 'spread': '6.86', 'groupId': 'OG000'}]}]}, {'title': '68 Swollen Joint Count: Week 8', 'categories': [{'measurements': [{'value': '-9.03', 'spread': '7.54', 'groupId': 'OG000'}]}]}, {'title': '68 Swollen Joint Count: Week 16', 'categories': [{'measurements': [{'value': '-10.49', 'spread': '7.62', 'groupId': 'OG000'}]}]}, {'title': '68 Swollen Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-11.53', 'spread': '8.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': '28 Tender Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-12.65', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '-12.35', 'spread': '6.45', 'groupId': 'OG001'}]}]}, {'title': '28 Tender Joint Count: Week 28', 'categories': [{'measurements': [{'value': '-11.69', 'spread': '6.74', 'groupId': 'OG000'}, {'value': '-10.08', 'spread': '7.84', 'groupId': 'OG001'}]}]}, {'title': '28 Tender Joint Count: Week 36', 'categories': [{'measurements': [{'value': '-11.22', 'spread': '6.91', 'groupId': 'OG000'}, {'value': '-9.23', 'spread': '8.07', 'groupId': 'OG001'}]}]}, {'title': '28 Tender Joint Count: Week 44', 'categories': [{'measurements': [{'value': '-11.19', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '-8.97', 'spread': '8.01', 'groupId': 'OG001'}]}]}, {'title': '28 Tender Joint Count: Week 52', 'categories': [{'measurements': [{'value': '-11.03', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '-8.78', 'spread': '7.83', 'groupId': 'OG001'}]}]}, {'title': '28 Swollen Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-9.78', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '-9.98', 'spread': '5.58', 'groupId': 'OG001'}]}]}, {'title': '28 Swollen Joint Count: Week 28', 'categories': [{'measurements': [{'value': '-8.97', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '-8.70', 'spread': '5.94', 'groupId': 'OG001'}]}]}, {'title': '28 Swollen Joint Count: Week 36', 'categories': [{'measurements': [{'value': '-8.64', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '-8.16', 'spread': '6.04', 'groupId': 'OG001'}]}]}, {'title': '28 Swollen Joint Count: Week 44', 'categories': [{'measurements': [{'value': '-8.71', 'spread': '5.52', 'groupId': 'OG000'}, {'value': '-8.03', 'spread': '6.08', 'groupId': 'OG001'}]}]}, {'title': '28 Swollen Joint Count: Week 52', 'categories': [{'measurements': [{'value': '-8.59', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '-7.98', 'spread': '6.05', 'groupId': 'OG001'}]}]}, {'title': '68 Tender Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-18.31', 'spread': '12.13', 'groupId': 'OG000'}, {'value': '-18.19', 'spread': '12.03', 'groupId': 'OG001'}]}]}, {'title': '68 Tender Joint Count: Week 28', 'categories': [{'measurements': [{'value': '-17.02', 'spread': '12.48', 'groupId': 'OG000'}, {'value': '-15.20', 'spread': '13.95', 'groupId': 'OG001'}]}]}, {'title': '68 Tender Joint Count: Week 36', 'categories': [{'measurements': [{'value': '-17.27', 'spread': '12.55', 'groupId': 'OG000'}, {'value': '-17.13', 'spread': '14.28', 'groupId': 'OG001'}]}]}, {'title': '68 Tender Joint Count: Week 44', 'categories': [{'measurements': [{'value': '-18.67', 'spread': '12.90', 'groupId': 'OG000'}, {'value': '-18.82', 'spread': '14.71', 'groupId': 'OG001'}]}]}, {'title': '68 Tender Joint Count: Week 52', 'categories': [{'measurements': [{'value': '-17.88', 'spread': '13.21', 'groupId': 'OG000'}, {'value': '-17.61', 'spread': '12.57', 'groupId': 'OG001'}]}]}, {'title': '68 Swollen Joint Count: Week 24', 'categories': [{'measurements': [{'value': '-12.09', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-12.40', 'spread': '8.45', 'groupId': 'OG001'}]}]}, {'title': '68 Swollen Joint Count: Week 28', 'categories': [{'measurements': [{'value': '-11.23', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '-10.81', 'spread': '8.66', 'groupId': 'OG001'}]}]}, {'title': '68 Swollen Joint Count: Week 36', 'categories': [{'measurements': [{'value': '-11.26', 'spread': '8.05', 'groupId': 'OG000'}, {'value': '-10.67', 'spread': '8.59', 'groupId': 'OG001'}]}]}, {'title': '68 Swollen Joint Count: Week 44', 'categories': [{'measurements': [{'value': '-12.00', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '-11.63', 'spread': '8.58', 'groupId': 'OG001'}]}]}, {'title': '68 Swollen Joint Count: Week 52', 'categories': [{'measurements': [{'value': '-11.98', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '-11.89', 'spread': '8.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '0.05', 'groupDescription': '28 Tender Joint Count: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.34', 'ciLowerLimit': '-2.41', 'ciUpperLimit': '-0.27', 'groupDescription': '28 Tender Joint Count: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.65', 'ciLowerLimit': '-2.72', 'ciUpperLimit': '-0.57', 'groupDescription': '28 Tender Joint Count: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.75', 'ciLowerLimit': '-2.85', 'ciUpperLimit': '-0.66', 'groupDescription': '28 Tender Joint Count: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.50', 'groupDescription': '28 Swollen Joint Count: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.45', 'groupDescription': '28 Swollen Joint Count: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.31', 'ciUpperLimit': '0.17', 'groupDescription': '28 Swollen Joint Count: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.199', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.25', 'groupDescription': '28 Swollen Joint Count: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.115', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '0.28', 'groupDescription': '68 Tender Joint Count: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.88', 'ciLowerLimit': '-3.42', 'ciUpperLimit': '-0.35', 'groupDescription': '68 Tender Joint Count: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.34', 'ciLowerLimit': '-3.91', 'ciUpperLimit': '-0.76', 'groupDescription': '68 Tender Joint Count: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.58', 'ciLowerLimit': '-4.19', 'ciUpperLimit': '-0.97', 'groupDescription': '68 Tender Joint Count: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '0.42', 'groupDescription': '68 Swollen Joint Count: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.208', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '0.32', 'groupDescription': '68 Swollen Joint Count: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-1.73', 'ciUpperLimit': '0.05', 'groupDescription': '68 Swollen Joint Count: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '0.10', 'groupDescription': '68 Swollen Joint Count: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '-2.60', 'spread': '1.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '-3.46', 'spread': '1.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '-4.12', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '-4.79', 'spread': '2.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-5.28', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-5.26', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-4.93', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-4.23', 'spread': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-4.83', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-3.89', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '-4.82', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '2.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-4.77', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-3.74', 'spread': '2.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.16', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '-0.38', 'groupDescription': 'Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-1.35', 'ciUpperLimit': '-0.54', 'groupDescription': 'Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.53', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Change in the Subject Global Assessment of Arthritis in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '-2.18', 'spread': '2.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '-2.60', 'spread': '2.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '-3.32', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '-3.97', 'spread': '2.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change in the Subject Global Assessment of Arthritis in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-4.39', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-4.64', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-4.03', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '-3.48', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-4.02', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '-3.05', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '-3.92', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-3.02', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-3.91', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '-3.02', 'spread': '2.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '-0.01', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.44', 'ciUpperLimit': '-0.43', 'groupDescription': 'Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.33', 'groupDescription': 'Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.31', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'Week 4 (N= 467)', 'categories': [{'measurements': [{'value': '-78.56', 'spread': '143.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N= 467)', 'categories': [{'measurements': [{'value': '-90.58', 'spread': '147.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (N= 467)', 'categories': [{'measurements': [{'value': '-102.25', 'spread': '158.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (N= 467)', 'categories': [{'measurements': [{'value': '-109.32', 'spread': '183.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'Week 24 (N= 163, 166)', 'categories': [{'measurements': [{'value': '-118.30', 'spread': '171.15', 'groupId': 'OG000'}, {'value': '-121.93', 'spread': '186.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (N= 163, 166)', 'categories': [{'measurements': [{'value': '-134.42', 'spread': '224.70', 'groupId': 'OG000'}, {'value': '-109.57', 'spread': '163.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (N= 163, 166)', 'categories': [{'measurements': [{'value': '-132.05', 'spread': '224.86', 'groupId': 'OG000'}, {'value': '-104.40', 'spread': '164.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 44 (N= 163, 166)', 'categories': [{'measurements': [{'value': '-129.86', 'spread': '223.78', 'groupId': 'OG000'}, {'value': '-103.14', 'spread': '162.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (N= 163, 166)', 'categories': [{'measurements': [{'value': '-129.49', 'spread': '223.68', 'groupId': 'OG000'}, {'value': '-100.31', 'spread': '153.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.11', 'ciLowerLimit': '-27.07', 'ciUpperLimit': '-1.16', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.04', 'ciLowerLimit': '-30.39', 'ciUpperLimit': '-3.68', 'groupDescription': 'Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.54', 'ciLowerLimit': '-30.35', 'ciUpperLimit': '-2.73', 'groupDescription': 'Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.66', 'ciLowerLimit': '-33.78', 'ciUpperLimit': '-5.54', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'General Health VAS: Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '-20.20', 'spread': '22.22', 'groupId': 'OG000'}]}]}, {'title': 'General Health VAS: Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '-25.17', 'spread': '24.59', 'groupId': 'OG000'}]}]}, {'title': 'General Health VAS: Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '-32.54', 'spread': '24.89', 'groupId': 'OG000'}]}]}, {'title': 'General Health VAS: Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '-40.67', 'spread': '26.28', 'groupId': 'OG000'}]}]}, {'title': 'Pain VAS: Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '-24.07', 'spread': '22.56', 'groupId': 'OG000'}]}]}, {'title': 'Pain VAS: Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '-28.55', 'spread': '24.08', 'groupId': 'OG000'}]}]}, {'title': 'Pain VAS: Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '-35.20', 'spread': '24.81', 'groupId': 'OG000'}]}]}, {'title': 'Pain VAS: Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '-42.49', 'spread': '26.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'Participants were asked to answer the question "In general how would you rate your health over the last 2 3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'General Health VAS: Week 24', 'categories': [{'measurements': [{'value': '-46.66', 'spread': '24.72', 'groupId': 'OG000'}, {'value': '-47.53', 'spread': '20.21', 'groupId': 'OG001'}]}]}, {'title': 'General Health VAS: Week 28', 'categories': [{'measurements': [{'value': '-41.31', 'spread': '27.01', 'groupId': 'OG000'}, {'value': '-34.95', 'spread': '28.95', 'groupId': 'OG001'}]}]}, {'title': 'General Health VAS: Week 36', 'categories': [{'measurements': [{'value': '-39.84', 'spread': '26.56', 'groupId': 'OG000'}, {'value': '-30.74', 'spread': '29.79', 'groupId': 'OG001'}]}]}, {'title': 'General Health VAS: Week 44', 'categories': [{'measurements': [{'value': '-39.82', 'spread': '27.61', 'groupId': 'OG000'}, {'value': '-30.10', 'spread': '29.88', 'groupId': 'OG001'}]}]}, {'title': 'General Health VAS: Week 52', 'categories': [{'measurements': [{'value': '-39.81', 'spread': '28.16', 'groupId': 'OG000'}, {'value': '-29.67', 'spread': '29.21', 'groupId': 'OG001'}]}]}, {'title': 'Pain VAS: Week 24', 'categories': [{'measurements': [{'value': '-46.61', 'spread': '24.33', 'groupId': 'OG000'}, {'value': '-49.69', 'spread': '20.64', 'groupId': 'OG001'}]}]}, {'title': 'Pain VAS: Week 28', 'categories': [{'measurements': [{'value': '-43.30', 'spread': '26.34', 'groupId': 'OG000'}, {'value': '-38.17', 'spread': '29.24', 'groupId': 'OG001'}]}]}, {'title': 'Pain VAS: Week 36', 'categories': [{'measurements': [{'value': '-41.42', 'spread': '27.01', 'groupId': 'OG000'}, {'value': '-34.00', 'spread': '30.30', 'groupId': 'OG001'}]}]}, {'title': 'Pain VAS: Week 44', 'categories': [{'measurements': [{'value': '-41.21', 'spread': '28.01', 'groupId': 'OG000'}, {'value': '-33.07', 'spread': '29.46', 'groupId': 'OG001'}]}]}, {'title': 'Pain VAS: Week 52', 'categories': [{'measurements': [{'value': '-40.95', 'spread': '28.61', 'groupId': 'OG000'}, {'value': '-32.91', 'spread': '29.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.21', 'ciLowerLimit': '-8.91', 'ciUpperLimit': '0.48', 'groupDescription': 'General Health VAS: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.54', 'ciLowerLimit': '-12.49', 'ciUpperLimit': '-2.59', 'groupDescription': 'General Health VAS: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.19', 'ciLowerLimit': '-13.20', 'ciUpperLimit': '-3.18', 'groupDescription': 'General Health VAS: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.60', 'ciLowerLimit': '-13.64', 'ciUpperLimit': '-3.55', 'groupDescription': 'General Health VAS: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.91', 'ciLowerLimit': '-10.75', 'ciUpperLimit': '-1.06', 'groupDescription': 'Pain VAS: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.60', 'ciLowerLimit': '-13.85', 'ciUpperLimit': '-3.34', 'groupDescription': 'Pain VAS: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.49', 'ciLowerLimit': '-14.72', 'ciUpperLimit': '-4.26', 'groupDescription': 'Pain VAS: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.29', 'ciLowerLimit': '-14.60', 'ciUpperLimit': '-3.99', 'groupDescription': 'Pain VAS: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'Participants were asked to answer the question "In general how would you rate your health over the last 2-3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}, {'type': 'SECONDARY', 'title': 'Change in CRP and ESR at Each Visit During Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).'}], 'classes': [{'title': 'CRP: Week 4 (N= 465)', 'categories': [{'measurements': [{'value': '-14.07', 'spread': '25.30', 'groupId': 'OG000'}]}]}, {'title': 'CRP: Week 8 (N= 471)', 'categories': [{'measurements': [{'value': '-14.43', 'spread': '23.51', 'groupId': 'OG000'}]}]}, {'title': 'CRP: Week 16 (N= 472)', 'categories': [{'measurements': [{'value': '-14.71', 'spread': '27.32', 'groupId': 'OG000'}]}]}, {'title': 'CRP: Week 24 (N= 472)', 'categories': [{'measurements': [{'value': '-14.51', 'spread': '27.64', 'groupId': 'OG000'}]}]}, {'title': 'ESR: Week 4 (N= 473)', 'categories': [{'measurements': [{'value': '-17.32', 'spread': '19.44', 'groupId': 'OG000'}]}]}, {'title': 'ESR: Week 8 (N= 473)', 'categories': [{'measurements': [{'value': '-19.28', 'spread': '21.62', 'groupId': 'OG000'}]}]}, {'title': 'ESR: Week 16 (N= 473)', 'categories': [{'measurements': [{'value': '-21.10', 'spread': '24.20', 'groupId': 'OG000'}]}]}, {'title': 'ESR: Week 24 (N= 473)', 'categories': [{'measurements': [{'value': '-26.77', 'spread': '26.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).'}, {'type': 'SECONDARY', 'title': 'Change in CRP and ESR at Each Visit During Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'classes': [{'title': 'CRP: Week 24 (N= 161, 168)', 'categories': [{'measurements': [{'value': '-16.92', 'spread': '28.64', 'groupId': 'OG000'}, {'value': '-14.47', 'spread': '21.59', 'groupId': 'OG001'}]}]}, {'title': 'CRP: Week 28 (N= 160, 166)', 'categories': [{'measurements': [{'value': '-15.94', 'spread': '28.52', 'groupId': 'OG000'}, {'value': '-8.59', 'spread': '25.46', 'groupId': 'OG001'}]}]}, {'title': 'CRP: Week 36 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-15.56', 'spread': '31.36', 'groupId': 'OG000'}, {'value': '-7.45', 'spread': '25.55', 'groupId': 'OG001'}]}]}, {'title': 'CRP: Week 44 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-16.47', 'spread': '30.09', 'groupId': 'OG000'}, {'value': '-6.72', 'spread': '26.32', 'groupId': 'OG001'}]}]}, {'title': 'CRP: Week 52 (N= 162, 167)', 'categories': [{'measurements': [{'value': '-16.29', 'spread': '30.74', 'groupId': 'OG000'}, {'value': '-7.07', 'spread': '26.76', 'groupId': 'OG001'}]}]}, {'title': 'ESR: Week 24 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-31.52', 'spread': '22.55', 'groupId': 'OG000'}, {'value': '-31.02', 'spread': '24.24', 'groupId': 'OG001'}]}]}, {'title': 'ESR: Week 28 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-26.96', 'spread': '23.04', 'groupId': 'OG000'}, {'value': '-20.28', 'spread': '23.68', 'groupId': 'OG001'}]}]}, {'title': 'ESR: Week 36 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-26.10', 'spread': '24.17', 'groupId': 'OG000'}, {'value': '-16.94', 'spread': '23.08', 'groupId': 'OG001'}]}]}, {'title': 'ESR: Week 44 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-24.39', 'spread': '22.99', 'groupId': 'OG000'}, {'value': '-16.14', 'spread': '23.10', 'groupId': 'OG001'}]}]}, {'title': 'ESR: Week 52 (N= 163, 168)', 'categories': [{'measurements': [{'value': '-23.56', 'spread': '21.88', 'groupId': 'OG000'}, {'value': '-16.27', 'spread': '22.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.22', 'ciLowerLimit': '-9.39', 'ciUpperLimit': '-1.05', 'groupDescription': 'CRP: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.27', 'ciLowerLimit': '-11.09', 'ciUpperLimit': '-1.46', 'groupDescription': 'CRP: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.75', 'ciLowerLimit': '-12.06', 'ciUpperLimit': '-3.44', 'groupDescription': 'CRP: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.16', 'ciLowerLimit': '-11.48', 'ciUpperLimit': '-2.85', 'groupDescription': 'CRP: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.86', 'ciLowerLimit': '-9.23', 'ciUpperLimit': '-2.49', 'groupDescription': 'ESR: Week 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.69', 'ciLowerLimit': '-12.33', 'ciUpperLimit': '-5.05', 'groupDescription': 'ESR: Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.59', 'ciLowerLimit': '-11.38', 'ciUpperLimit': '-3.80', 'groupDescription': 'ESR: Week 44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.32', 'ciLowerLimit': '-10.03', 'ciUpperLimit': '-2.60', 'groupDescription': 'ESR: Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\\<2.6 or Stratum 2=LDA: 2.6\\<=DAS28-ESR\\<3.2).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-Label Treatment', 'description': 'Participants in open-label treatment received Etanercept (ETN) 50 milligram (mg) once a week (QW) with MTX (with or without other DMARDs).'}, {'id': 'FG001', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '491 participants were enrolled in open-label treatment but 2 did not receive study medication.', 'groupId': 'FG000', 'numSubjects': '489'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '452'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Insufficient Clinical Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Does Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Two participants in ETN did not receive treatment.', 'groupId': 'FG001', 'numSubjects': '167'}, {'comment': 'One participants in PBO did not receive treatment.', 'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '162'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Insufficient Clinical Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Unspecified Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study consisted of Period 1 (an open-label, 24-week treat-to-target period), and Period 2 (a double-blind, randomized, 28-week period for participants who qualified for randomization).', 'preAssignmentDetails': 'The study was conducted in participants with rheumatoid arthritis (RA) who had moderate to severe disease activity despite methotrexate (MTX) therapy (≥10 mg/week) with or without other non-biologic disease modifying anti-rheumatic drugs (DMARDs) for at least 12 weeks prior to screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive PBO 50 mg QW with MTX (with or without other DMARDs).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'spread': '12.88', 'groupId': 'BG000'}, {'value': '47.0', 'spread': '12.02', 'groupId': 'BG001'}, {'value': '46.6', 'spread': '12.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set for Period 2 (Double Blind FAS) included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or placebo) and have at least one valid efficacy (DAS28-ESR) evaluation after randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2012-04-12', 'resultsFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-25', 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.', 'timeFrame': 'Baseline and Week 52', 'description': 'Proportion of participants who remained in LDA DAS28-ESR \\<3.2 at Week 52 is presented below.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)', 'timeFrame': 'Baseline and Week 52', 'description': 'Proportion of participants who remained in Remission (DAS28-ESR \\<2.6) at Week 52.'}, {'measure': 'Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.'}, {'measure': 'Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.'}, {'measure': 'Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.'}, {'measure': 'Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.'}, {'measure': 'Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.'}, {'measure': 'Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.'}, {'measure': 'Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria', 'timeFrame': 'Baseline and Week 52', 'description': 'Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.'}, {'measure': 'Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (\\>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.'}, {'measure': 'Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (\\>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.'}, {'measure': 'Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.'}, {'measure': 'Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.'}, {'measure': 'Change of CDAI and SDAI at Each Visit During Period 1.', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.'}, {'measure': 'Change of CDAI and SDAI at Each Visit During Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'SDAI and CDAI are defined as:\n\n1\\) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit."}, {'measure': 'Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit."}, {'measure': 'Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.'}, {'measure': 'Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.'}, {'measure': 'Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'."}, {'measure': 'Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'."}, {'measure': 'Change in the Subject Global Assessment of Arthritis in Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'."}, {'measure': 'Change in the Subject Global Assessment of Arthritis in Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'."}, {'measure': 'Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': "Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'."}, {'measure': 'Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': "Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'."}, {'measure': 'Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'Participants were asked to answer the question "In general how would you rate your health over the last 2 3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.'}, {'measure': 'Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'Participants were asked to answer the question "In general how would you rate your health over the last 2-3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.'}, {'measure': 'Change in CRP and ESR at Each Visit During Period 1', 'timeFrame': 'Baseline, Weeks 4, 8, 16 and 24', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.'}, {'measure': 'Change in CRP and ESR at Each Visit During Period 2', 'timeFrame': 'Baseline, Weeks 24, 28, 36, 44 and 52', 'description': 'The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'etanercept', 'methotrexate', 'DMARDs'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31277720', 'type': 'DERIVED', 'citation': 'Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.'}, {'pmid': '30200078', 'type': 'DERIVED', 'citation': 'Zerbini CAF, Abud-Mendoza C, Mendez-Patarroyo P, De Angelo Andrade M, Pedersen R, Vlahos B, Borlenghi CE. Maintenance of low disease activity and remission with etanercept-disease-modifying antirheumatic drug (DMARD) combination therapy compared with treatment with DMARDs alone in Latin American patients with active rheumatoid arthritis: Subset analysis of a randomized trial. Medicine (Baltimore). 2018 Sep;97(36):e11989. doi: 10.1097/MD.0000000000011989.'}, {'pmid': '28597306', 'type': 'DERIVED', 'citation': 'Pavelka K, Akkoc N, Al-Maini M, Zerbini CAF, Karateev DE, Nasonov EL, Rahman MU, Pedersen R, Dinh A, Shen Q, Vasilescu R, Kotak S, Mahgoub E, Vlahos B. Maintenance of remission with combination etanercept-DMARD therapy versus DMARDs alone in active rheumatoid arthritis: results of an international treat-to-target study conducted in regions with limited biologic access. Rheumatol Int. 2017 Sep;37(9):1469-1479. doi: 10.1007/s00296-017-3749-7. Epub 2017 Jun 9.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801315&StudyName=Study%20conducted%20in%20subjects%20with%20rheumatoid%20arthritis%20who%20have%20moderate%20to%20severe%20disease%20activity%20despite%20methotrexate%20therapy%20with%20or%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.\n2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.\n\nExclusion Criteria:\n\n1. Subjects who used any of the following systemic treatments during the washout periods given below:\n\n 1. Oral corticosteroid dose of prednisone \\>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.\n 2. Treatment with more than 1 NSAID within 14 days at baseline.\n 3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.\n 4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.\n 5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.\n2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.\n3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.'}, 'identificationModule': {'nctId': 'NCT01578850', 'briefTitle': 'Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)', 'orgStudyIdInfo': {'id': 'B1801315'}, 'secondaryIdInfos': [{'id': '2011-005448-87', 'type': 'EUDRACT_NUMBER'}, {'id': 'B1801315', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Drug: Etanercept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'description': 'etanercept 50mg once weekly + methotrexate with or without other DMARDs', 'armGroupLabels': ['Group A']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'etanercept placebo once weekly + methotrexate with or without other DMARDs', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40050-410', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '74110-120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'CIP (Centro Internacional de Pesquisa)', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '04209-003', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos LTDA', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Juiz de Fora', 'country': 'Brazil', 'facility': 'Research Center', 'geoPoint': {'lat': -21.76417, 'lon': -43.35028}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '100050', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese Academy of Medical Sciences - Peking Union Medical C', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200052', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changning District Guanghua Hospital of Traditional Chinese and Western Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changhai Hospital[Rheumatology &Immunology]', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Santa Fe de Antioquia', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobon Uribe (HPTU)', 'geoPoint': {'lat': 6.55687, 'lon': -75.82806}}, {'zip': '99999', 'city': 'Barranquilla', 'state': 'Atlántico', 'country': 'Colombia', 'facility': 'Centro Integral de reumatolo[Gerencia / Representante Legal]', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogota DC', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Fundacion Instituto de Reumatologia Fernando Chalem'}, {'zip': '775 20', 'city': 'Olomouc', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Revmatologicka poradna III. 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