Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00688103
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2008-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hideto.kameda@med.toho-u.ac.jp', 'phone': '+81-3-3468-1251', 'title': 'Dr. Hideto Kameda', 'phoneExt': '2326', 'organization': 'School of Medicine, Toho University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ETN Alone', 'description': 'Etanercept alone treatment group (25mg, twice/week, s.c.)', 'otherNumAtRisk': 71, 'otherNumAffected': 34, 'seriousNumAtRisk': 71, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'ETN+MTX', 'description': 'Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)', 'otherNumAtRisk': 76, 'otherNumAffected': 39, 'seriousNumAtRisk': 76, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'upper airway viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 55, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 55, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastroentelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mild injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'bone fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'brain hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mammary carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'EULAR Good Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN Alone', 'description': 'Etanercept alone treatment group (25mg, twice/week, s.c.)'}, {'id': 'OG001', 'title': 'ETN+MTX', 'description': 'Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '52.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 24 weeks', 'description': 'EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by \\> 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 \\< 3.2 is regarded as low disease activity.', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'ACR50 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN Alone', 'description': 'Etanercept alone treatment group (25mg, twice/week, s.c.)'}, {'id': 'OG001', 'title': 'ETN+MTX', 'description': 'Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)'}], 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 24 weeks', 'description': 'ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN Alone', 'description': 'etanercept (25mg, twice/week, s.c.)\n\nETN Alone: etanercept (25 mg, twice/week, s.c.)'}, {'id': 'OG001', 'title': 'ETN+MTX', 'description': 'etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)\n\nETN+MTX: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 52 weeks', 'description': 'The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively.\n\nErosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet.\n\nFor joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, \\<50% of the original joint space; 3=general, \\>50% of the original joint space or subluxation; 4=ankylosis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ETN Alone', 'description': 'Etanercept alone treatment group (25mg, twice/week, s.c.)'}, {'id': 'FG001', 'title': 'ETN+MTX', 'description': 'Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'Actually Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'complex reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ETN Alone', 'description': 'Etanercept alone treatment group (25mg, twice/week, s.c.)'}, {'id': 'BG001', 'title': 'ETN+MTX', 'description': 'Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '56.6', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2008-05-25', 'resultsFirstSubmitDate': '2012-03-29', 'studyFirstSubmitQcDate': '2008-05-30', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-01', 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EULAR Good Response', 'timeFrame': 'at 24 weeks', 'description': 'EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by \\> 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 \\< 3.2 is regarded as low disease activity.'}, {'measure': 'ACR50 Response Rate', 'timeFrame': 'at 24 weeks', 'description': 'ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).'}, {'measure': 'Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score', 'timeFrame': 'at 52 weeks', 'description': 'The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively.\n\nErosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet.\n\nFor joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, \\<50% of the original joint space; 3=general, \\>50% of the original joint space or subluxation; 4=ankylosis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '20574649', 'type': 'RESULT', 'citation': 'Kameda H, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Takeuchi T; Japan Biological Agent Study Integrated Consortium. Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial. Mod Rheumatol. 2010 Dec;20(6):531-8. doi: 10.1007/s10165-010-0324-4. Epub 2010 Jun 24.'}, {'pmid': '21572151', 'type': 'RESULT', 'citation': 'Kameda H, Kanbe K, Sato E, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Yamanaka H, Takeuchi T. Continuation of methotrexate resulted in better clinical and radiographic outcomes than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from the JESMR study. J Rheumatol. 2011 Aug;38(8):1585-92. doi: 10.3899/jrheum.110014. Epub 2011 May 15.'}, {'pmid': '22975754', 'type': 'RESULT', 'citation': 'Kameda H, Kanbe K, Sato E, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, Tsukano M, Kasama T, Shiozawa S, Tanaka Y, Yamanaka H, Takeuchi T; Japan Biological Agent Integrated Consortium (JBASIC). A merged presentation of clinical and radiographic data using probability plots in a clinical trial, the JESMR study. Ann Rheum Dis. 2013 Feb;72(2):310-2. doi: 10.1136/annrheumdis-2012-201804. Epub 2012 Sep 12. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.\n\n1. Etanercept alone treatment group (25mg, twice/week, s.c.)\n2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients had to be at least 18 years of age\n* fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR)\n* met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints\n* either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles)\n* be ACR functional class I-III\n* have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment\n\nExclusion Criteria:\n\n* Patients who required concurrent use of prednisone (PSL) \\>10 mg/day, or its equivalent, were excluded from study entry\n* the start of dose increment of PSL equivalents within 3 months of the study enrollment\n* experience of antirheumatic therapy except for MTX and PSL equivalents\n* previous treatment with ETN or any other biological treatment'}, 'identificationModule': {'nctId': 'NCT00688103', 'acronym': 'JESMR', 'briefTitle': 'Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan', 'organization': {'class': 'NETWORK', 'fullName': 'Japan Biological Agent Study Integrated Consortium'}, 'officialTitle': 'Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan', 'orgStudyIdInfo': {'id': 'Etanercept-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ETN Alone', 'description': 'etanercept (25mg, twice/week, s.c.)', 'interventionNames': ['Drug: ETN Alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ETN+MTX', 'description': 'etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)', 'interventionNames': ['Drug: ETN+MTX']}], 'interventions': [{'name': 'ETN Alone', 'type': 'DRUG', 'otherNames': ['etanercept'], 'description': 'etanercept (25 mg, twice/week, s.c.)', 'armGroupLabels': ['ETN Alone']}, {'name': 'ETN+MTX', 'type': 'DRUG', 'otherNames': ['etanercept and methotrexate'], 'description': 'etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)', 'armGroupLabels': ['ETN+MTX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160-8582', 'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Tsutomu Takeuchi, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'JBASIC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Biological Agent Study Integrated Consortium', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Toho University', 'investigatorFullName': 'Hideto Kameda', 'investigatorAffiliation': 'Japan Biological Agent Study Integrated Consortium'}}}}