Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT00422227
Status:
COMPLETED
Last Update Posted:
2010-08-30
First Post:
2007-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D012460', 'term': 'Sulfasalazine'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintrialresults@wyeth.com', 'title': 'U. S. Contact Center', 'organization': 'Wyeth'}, 'certainAgreement': {'otherDetails': 'The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.', 'otherNumAtRisk': 197, 'otherNumAffected': 66, 'seriousNumAtRisk': 197, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.', 'otherNumAtRisk': 103, 'otherNumAffected': 71, 'seriousNumAtRisk': 103, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '434.83', 'spread': '29.18', 'groupId': 'OG000'}, {'value': '289.54', 'spread': '36.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening.\n\nThe ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR 20, 50, and 70 Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'title': 'ACR 20', 'categories': [{'measurements': [{'value': '78.87', 'groupId': 'OG000'}, {'value': '58.16', 'groupId': 'OG001'}]}]}, {'title': 'ACR 50', 'categories': [{'measurements': [{'value': '56.70', 'groupId': 'OG000'}, {'value': '34.69', 'groupId': 'OG001'}]}]}, {'title': 'ACR 70', 'categories': [{'measurements': [{'value': '19.07', 'groupId': 'OG000'}, {'value': '7.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'ACR 20', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'ACR 50', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'ACR 70', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'title': 'Low Disease (DAS28 <3.2)', 'categories': [{'measurements': [{'value': '39.09', 'groupId': 'OG000'}, {'value': '18.45', 'groupId': 'OG001'}]}]}, {'title': 'Remission (DAS28 <2.6)', 'categories': [{'measurements': [{'value': '15.74', 'groupId': 'OG000'}, {'value': '7.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Low Disease (DAS28 \\<3.2)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Remission (DAS28 \\<2.6)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in DAS28 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.32', 'groupId': 'OG000'}, {'value': '27.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).', 'unitOfMeasure': 'Percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.82', 'groupId': 'OG000'}, {'value': '73.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as \\>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of \\>0.6 but ≤1.2 and DAS attained during follow-up of \\>3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'title': '≥0.6', 'categories': [{'measurements': [{'value': '91.37', 'groupId': 'OG000'}, {'value': '78.64', 'groupId': 'OG001'}]}]}, {'title': '≥1.2', 'categories': [{'measurements': [{'value': '82.74', 'groupId': 'OG000'}, {'value': '66.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': '≥0.6', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': '≥1.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Painful and Swollen Joint Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'title': 'Painful Joints - Week 2', 'categories': [{'measurements': [{'value': '34.17', 'groupId': 'OG000'}, {'value': '27.68', 'groupId': 'OG001'}]}]}, {'title': 'Painful Joints - Week 4', 'categories': [{'measurements': [{'value': '46.11', 'groupId': 'OG000'}, {'value': '36.71', 'groupId': 'OG001'}]}]}, {'title': 'Painful Joints - Week 8', 'categories': [{'measurements': [{'value': '55.48', 'groupId': 'OG000'}, {'value': '49.71', 'groupId': 'OG001'}]}]}, {'title': 'Painful Joints - Week 12', 'categories': [{'measurements': [{'value': '65.65', 'groupId': 'OG000'}, {'value': '55.55', 'groupId': 'OG001'}]}]}, {'title': 'Painful Joints - Week 16', 'categories': [{'measurements': [{'value': '68.99', 'groupId': 'OG000'}, {'value': '57.31', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joints - Week 2', 'categories': [{'measurements': [{'value': '38.59', 'groupId': 'OG000'}, {'value': '21.32', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joints - Week 4', 'categories': [{'measurements': [{'value': '49.33', 'groupId': 'OG000'}, {'value': '27.72', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joints - Week 8', 'categories': [{'measurements': [{'value': '59.91', 'groupId': 'OG000'}, {'value': '44.19', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joints - Week 12', 'categories': [{'measurements': [{'value': '67.97', 'groupId': 'OG000'}, {'value': '50.48', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joints - Week 16', 'categories': [{'measurements': [{'value': '73.83', 'groupId': 'OG000'}, {'value': '56.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Painful Joints at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Swollen Joints at Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': "Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen.", 'unitOfMeasure': 'Percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Physician And Subject Global Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'title': 'Physician Global Assessment - Week 2', 'categories': [{'measurements': [{'value': '30.40', 'groupId': 'OG000'}, {'value': '11.83', 'groupId': 'OG001'}]}]}, {'title': 'Physician Global Assessment - Week 4', 'categories': [{'measurements': [{'value': '39.58', 'groupId': 'OG000'}, {'value': '22.81', 'groupId': 'OG001'}]}]}, {'title': 'Physician Global Assessment - Week 8', 'categories': [{'measurements': [{'value': '45.86', 'groupId': 'OG000'}, {'value': '35.41', 'groupId': 'OG001'}]}]}, {'title': 'Physician Global Assessment - Week 12', 'categories': [{'measurements': [{'value': '55.00', 'groupId': 'OG000'}, {'value': '38.67', 'groupId': 'OG001'}]}]}, {'title': 'Physician Global Assessment - Week 16', 'categories': [{'measurements': [{'value': '62.05', 'groupId': 'OG000'}, {'value': '45.04', 'groupId': 'OG001'}]}]}, {'title': 'Subject Global Assessment - Week 2', 'categories': [{'measurements': [{'value': '21.84', 'groupId': 'OG000'}, {'value': '7.24', 'groupId': 'OG001'}]}]}, {'title': 'Subject Global Assessment - Week 4', 'categories': [{'measurements': [{'value': '28.94', 'groupId': 'OG000'}, {'value': '19.22', 'groupId': 'OG001'}]}]}, {'title': 'Subject Global Assessment - Week 8', 'categories': [{'measurements': [{'value': '34.92', 'groupId': 'OG000'}, {'value': '26.08', 'groupId': 'OG001'}]}]}, {'title': 'Subject Global Assessment - Week 12', 'categories': [{'measurements': [{'value': '43.18', 'groupId': 'OG000'}, {'value': '30.10', 'groupId': 'OG001'}]}]}, {'title': 'Subject Global Assessment - Week 16', 'categories': [{'measurements': [{'value': '50.76', 'groupId': 'OG000'}, {'value': '30.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Physician Global Assessment Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Subject Global Assessment Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': "The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity.", 'unitOfMeasure': 'Percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Duration (Minutes) of Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '54.92', 'groupId': 'OG000'}, {'value': '16.43', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '63.85', 'groupId': 'OG000'}, {'value': '33.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '73.41', 'groupId': 'OG000'}, {'value': '37.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '79.76', 'groupId': 'OG000'}, {'value': '52.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '80.55', 'groupId': 'OG000'}, {'value': '46.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': 'The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.', 'unitOfMeasure': 'Percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'OG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'classes': [{'title': 'General Health - Week 2', 'categories': [{'measurements': [{'value': '21.14', 'groupId': 'OG000'}, {'value': '8.88', 'groupId': 'OG001'}]}]}, {'title': 'General Health - Week 4', 'categories': [{'measurements': [{'value': '30.61', 'groupId': 'OG000'}, {'value': '22.78', 'groupId': 'OG001'}]}]}, {'title': 'General Health - Week 8', 'categories': [{'measurements': [{'value': '38.57', 'groupId': 'OG000'}, {'value': '27.86', 'groupId': 'OG001'}]}]}, {'title': 'General Health - Week 12', 'categories': [{'measurements': [{'value': '42.10', 'groupId': 'OG000'}, {'value': '30.26', 'groupId': 'OG001'}]}]}, {'title': 'General Health - Week 16', 'categories': [{'measurements': [{'value': '50.49', 'groupId': 'OG000'}, {'value': '33.89', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Week 2', 'categories': [{'measurements': [{'value': '27.59', 'groupId': 'OG000'}, {'value': '9.99', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Week 4', 'categories': [{'measurements': [{'value': '34.73', 'groupId': 'OG000'}, {'value': '22.98', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Week 8', 'categories': [{'measurements': [{'value': '42.97', 'groupId': 'OG000'}, {'value': '29.14', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Week 12', 'categories': [{'measurements': [{'value': '48.46', 'groupId': 'OG000'}, {'value': '33.97', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Week 16', 'categories': [{'measurements': [{'value': '54.42', 'groupId': 'OG000'}, {'value': '36.45', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - Week 2', 'categories': [{'measurements': [{'value': '20.90', 'groupId': 'OG000'}, {'value': '6.63', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - Week 4', 'categories': [{'measurements': [{'value': '30.87', 'groupId': 'OG000'}, {'value': '19.00', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - Week 8', 'categories': [{'measurements': [{'value': '35.92', 'groupId': 'OG000'}, {'value': '21.82', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - Week 12', 'categories': [{'measurements': [{'value': '39.65', 'groupId': 'OG000'}, {'value': '28.65', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - Week 16', 'categories': [{'measurements': [{'value': '46.92', 'groupId': 'OG000'}, {'value': '30.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'General Health Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Pain Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Fatigue Week 16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': 'VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, "in general how would you rate your heath over the last 2-3 weeks", 0mm equals very well and 100mm equals extremely bad. Pain VAS: "indicate the amount of pain experienced during the last 2-3 days", 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: "how fatigued or tired have you been over the last week", range =No Fatigue - Extremely Fatigued.', 'unitOfMeasure': 'Percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.', 'anticipatedPostingDate': '2010-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'FG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Subjects were recruited in the Asia-Pacific Region from June 2007 to October 2008.', 'preAssignmentDetails': 'Screening of subjects occurred up to 2 weeks before randomization followed by a treatment phase of 16 weeks and a 2-week safety follow up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ETN/MTX', 'description': 'Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.'}, {'id': 'BG001', 'title': 'DMARD/MTX', 'description': 'Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.38', 'spread': '11.98', 'groupId': 'BG000'}, {'value': '48.52', 'spread': '11.25', 'groupId': 'BG001'}, {'value': '48.43', 'spread': '11.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-28', 'studyFirstSubmitDate': '2007-01-11', 'resultsFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2007-01-11', 'lastUpdatePostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-28', 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks', 'timeFrame': '16 weeks', 'description': 'ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening.\n\nThe ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving ACR 20, 50, and 70 Responses', 'timeFrame': 'Week 16', 'description': 'Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.'}, {'measure': 'Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)', 'timeFrame': 'Week 16', 'description': 'Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).'}, {'measure': 'Percent Change From Baseline in DAS28 at Week 16', 'timeFrame': 'Week 16', 'description': 'Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).'}, {'measure': 'Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response', 'timeFrame': 'Week 16', 'description': 'EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as \\>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of \\>0.6 but ≤1.2 and DAS attained during follow-up of \\>3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.'}, {'measure': 'Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2', 'timeFrame': 'Week 16', 'description': 'Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).'}, {'measure': 'Percent Change From Baseline in Painful and Swollen Joint Counts', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': "Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen."}, {'measure': 'Percent Change From Baseline in Physician And Subject Global Assessments', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': "The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity."}, {'measure': 'Percent Change From Baseline in Duration (Minutes) of Morning Stiffness', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': 'The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.'}, {'measure': 'Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales', 'timeFrame': 'Week 2, 4, 8, 12, 16', 'description': 'VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, "in general how would you rate your heath over the last 2-3 weeks", 0mm equals very well and 100mm equals extremely bad. Pain VAS: "indicate the amount of pain experienced during the last 2-3 days", 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: "how fatigued or tired have you been over the last week", range =No Fatigue - Extremely Fatigued.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '24907147', 'type': 'DERIVED', 'citation': 'Fleischmann R, Koenig AS, Szumski A, Nab HW, Marshall L, Bananis E. Short-term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis. Rheumatology (Oxford). 2014 Nov;53(11):1984-93. doi: 10.1093/rheumatology/keu235. Epub 2014 Jun 6.'}, {'pmid': '23294908', 'type': 'DERIVED', 'citation': 'Bae SC, Gun SC, Mok CC, Khandker R, Nab HW, Koenig AS, Vlahos B, Pedersen R, Singh A. Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis. BMC Musculoskelet Disord. 2013 Jan 8;14:13. doi: 10.1186/1471-2474-14-13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RA\n* Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA\n* Active RA at time of screening and baseline\n\nExclusion Criteria:\n\n* Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents\n* Concurrent treatment with a DMARD, other than MTX, at screening\n* Receipt of any DMARD, other than MTX, within 3 months before screening'}, 'identificationModule': {'nctId': 'NCT00422227', 'briefTitle': 'Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '0881A1-408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Etanercept + Methotrexate', 'interventionNames': ['Drug: Etanercept , Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide', 'interventionNames': ['Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide']}], 'interventions': [{'name': 'Etanercept , Methotrexate', 'type': 'DRUG', 'description': '* Etanercept: 25 mg twice weekly over 16 weeks, SC\n* Methotrexate: \\> 7.5 mg/week and no more than 25 mg/week, PO', 'armGroupLabels': ['1']}, {'name': 'Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide', 'type': 'DRUG', 'description': '* Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO\n* Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO\n* Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day\n* Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '560017', 'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560034', 'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '500082', 'city': 'Hyderabaad', 'country': 'India'}, {'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '30450', 'city': 'Ipoh, Perak', 'country': 'Malaysia'}, {'zip': '68100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '10450', 'city': 'Pulau Pinang', 'country': 'Malaysia', 'geoPoint': {'lat': 3.55, 'lon': 102.56667}}, {'zip': '62250', 'city': 'Putrajaya', 'country': 'Malaysia', 'geoPoint': {'lat': 2.93527, 'lon': 101.69112}}, {'zip': '70300', 'city': 'Seremban', 'country': 'Malaysia', 'geoPoint': {'lat': 2.7297, 'lon': 101.9381}}, {'zip': '6000', 'city': 'Cebu', 'country': 'Philippines', 'geoPoint': {'lat': 16.75187, 'lon': 121.5961}}, {'zip': '1200', 'city': 'Makati City', 'country': 'Philippines', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1004', 'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1500', 'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1102', 'city': 'Quezon City', 'country': 'Philippines', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '400-711', 'city': 'Incheon', 'state': 'Korea', 'country': 'South Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '133-792', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Hong Kong: medinfo@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Taiwan: medinfo@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}