Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-28 @ 9:10 PM
Study NCT ID:
NCT00965757
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2009-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
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': 'C077313', 'term': 'T 614'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+81-3-3817-5238', 'title': 'Kota Nagai', 'organization': 'Eisai Co., Ltd.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.', 'description': 'Treatment emergent adverse events are presented in this section.', 'eventGroups': [{'id': 'EG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.', 'otherNumAtRisk': 164, 'otherNumAffected': 135, 'seriousNumAtRisk': 164, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.', 'otherNumAtRisk': 88, 'otherNumAffected': 43, 'seriousNumAtRisk': 88, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).', 'otherNumAtRisk': 68, 'otherNumAffected': 41, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 71, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 48, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 44, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Beta 2 microglobulin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Beta 2 microglobulin urine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Blood iron decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 71, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 26, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}], 'seriousEvents': [{'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Gastroduodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Fallopian tube cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver.13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Counts and Swollen Joint Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Baseline: TJC', 'categories': [{'measurements': [{'value': '12.5', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '13.8', 'spread': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline at week 24 LOCF: TJC', 'categories': [{'measurements': [{'value': '-7.4', 'spread': '6', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '7.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline at week 52 LOCF: TJC', 'categories': [{'measurements': [{'value': '-8.4', 'spread': '6.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-9.9', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: SJC', 'categories': [{'measurements': [{'value': '11.5', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline at week 24 LOCF: SJC', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '6.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline at week 52 LOCF: SJC', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '6.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '6.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)', 'unitOfMeasure': 'joint counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PAP, PtGADA and PyGADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Baseline PAP', 'categories': [{'measurements': [{'value': '47.5', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '23.1', 'groupId': 'OG001'}, {'value': '44.8', 'spread': '22.4', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline in PAP: week 24 LOCF', 'categories': [{'measurements': [{'value': '-22', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '27', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline in PAP: week 52 LOCF', 'categories': [{'measurements': [{'value': '-24', 'spread': '24.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-21.4', 'spread': '26.6', 'groupId': 'OG002'}]}]}, {'title': 'Baseline PtGADA', 'categories': [{'measurements': [{'value': '47.7', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '48.4', 'spread': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline in PtGADA: week 24 LOCF', 'categories': [{'measurements': [{'value': '-21.2', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '-5', 'spread': '27.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline in PtGADA: week 52 LOCF', 'categories': [{'measurements': [{'value': '-24.3', 'spread': '26', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-23.1', 'spread': '27.7', 'groupId': 'OG002'}]}]}, {'title': 'Baseline PyGADA', 'categories': [{'measurements': [{'value': '52.6', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '53.2', 'spread': '19', 'groupId': 'OG001'}, {'value': '52.1', 'spread': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline in PyGADA: week 24 LOCF', 'categories': [{'measurements': [{'value': '-27.1', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '26.6', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline in PyGADA: week 52 LOCF', 'categories': [{'measurements': [{'value': '-29.1', 'spread': '22.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-29.9', 'spread': '24.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': "Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0-100 mm, with higher scores indicating severe disease.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.8178', 'spread': '0.5525', 'groupId': 'OG000'}, {'value': '0.7344', 'spread': '0.5117', 'groupId': 'OG001'}, {'value': '0.7188', 'spread': '0.5274', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 LOCF', 'categories': [{'measurements': [{'value': '-0.3544', 'spread': '0.4492', 'groupId': 'OG000'}, {'value': '0.0256', 'spread': '0.549', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 LOCF', 'categories': [{'measurements': [{'value': '-0.4093', 'spread': '0.4566', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-0.2904', 'spread': '0.4669', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.843', 'spread': '1.943', 'groupId': 'OG000'}, {'value': '1.705', 'spread': '1.583', 'groupId': 'OG001'}, {'value': '1.714', 'spread': '1.611', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 LOCF', 'categories': [{'measurements': [{'value': '-0.528', 'spread': '2.067', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '2.028', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 LOCF', 'categories': [{'measurements': [{'value': '-0.609', 'spread': '1.841', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-0.581', 'spread': '1.866', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'Assessment of individual ACR core components i.e. CRP', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.6', 'spread': '21', 'groupId': 'OG000'}, {'value': '41.8', 'spread': '22.5', 'groupId': 'OG001'}, {'value': '40.1', 'spread': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 LOCF', 'categories': [{'measurements': [{'value': '-9.3', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '19.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 LOCF', 'categories': [{'measurements': [{'value': '-9.4', 'spread': '21.3', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '-8.8', 'spread': '21.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'Assessment of individual ACR core components i.e. ESR', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Remission: week 24 LOCF', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Remission: week 52 LOCF', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Low Disease Activity: week 24 LOCF', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002'}]}]}, {'title': 'Low Disease Activity: week 52 LOCF', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': "The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'SECONDARY', 'title': 'Percentage of ACR 50 Criteria Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Week 24 LOCF', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '30.9', 'upperLimit': '46.3'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '25.2'}, {'value': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 52 LOCF', 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000', 'lowerLimit': '41.5', 'upperLimit': '57.3'}, {'value': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '45.6', 'groupId': 'OG002', 'lowerLimit': '33.5', 'upperLimit': '58.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \\[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\\].', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'SECONDARY', 'title': 'Percentage of ACR 70 Criteria Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Week 24 LOCF', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '23.7'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '12.8'}, {'value': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 52 LOCF', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '31'}, {'value': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '22.1', 'groupId': 'OG002', 'lowerLimit': '12.9', 'upperLimit': '33.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \\[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\\].', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Double-blind), Efficacy Analysis Set (Extension)'}, {'type': 'PRIMARY', 'title': 'Percentage of American College of Rheumatology [ACR] 20 Criteria Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.\n\nExtension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'OG002', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'classes': [{'title': 'Week 24 LOCF', 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000', 'lowerLimit': '61.9', 'upperLimit': '76.5'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '41.4'}, {'value': 'NA', 'comment': 'Week 24 is not applicable as this arm starts from week 29 to week 52', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 52 LOCF', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '78.1'}, {'value': 'NA', 'comment': 'Week 52 is not applicable as this arm completed at week 28', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '72.1', 'groupId': 'OG002', 'lowerLimit': '59.9', 'upperLimit': '82.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)', 'description': 'ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \\[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\\].', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T-614 (Double-blind, 1-28 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'FG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'FG002', 'title': 'T-614 (Extension, 29-52 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'FG003', 'title': 'Placebo/T-614 (Extension, 29-52 Weeks)', 'description': 'Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).'}], 'periods': [{'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progression of concomitant disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse drug reaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Abnormal Laboratory Value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Drug Refusal Due to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Ineligible after Taking Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '165'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '132'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Progression of concomitant disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse drug reaction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Abnormal Laboratory Value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Drug Refusal Due to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Ineligible after Taking Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T-614 (Double-blind, 1-28 Weeks)', 'description': 'T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.'}, {'id': 'BG001', 'title': 'Placebo (Double-blind, 1-28 Weeks)', 'description': 'Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '10', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Rheumatoid Arthritis', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '35', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '34', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '34.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline characteristics are presented based on full analysis set, defined as all randomized patients who received at least one dose of study drug and from whom at least one assessment of efficacy under double-blind medication was available.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2011-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2009-08-25', 'resultsFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-15', 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of American College of Rheumatology [ACR] 20 Criteria Responders', 'timeFrame': 'Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)', 'description': 'ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \\[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\\].'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Tender Joint Counts and Swollen Joint Counts', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)'}, {'measure': 'Change From Baseline in PAP, PtGADA and PyGADA', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': "Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0-100 mm, with higher scores indicating severe disease."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.'}, {'measure': 'Change From Baseline in C-reactive Protein (CRP)', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'Assessment of individual ACR core components i.e. CRP'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'Assessment of individual ACR core components i.e. ESR'}, {'measure': 'Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': "The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity)."}, {'measure': 'Percentage of ACR 50 Criteria Responders', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \\[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\\].'}, {'measure': 'Percentage of ACR 70 Criteria Responders', 'timeFrame': 'Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)', 'description': 'ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \\[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\\].'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria\n* Age greater or 20 years and less than 70 years old\n\nExclusion criteria:\n\n* Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study\n* Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant'}, 'identificationModule': {'nctId': 'NCT00965757', 'briefTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate', 'orgStudyIdInfo': {'id': 'T614-ADN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: T-614']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'T-614', 'type': 'DRUG', 'description': 'T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anjo', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'city': 'Ichinomiya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Okazaki', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.95, 'lon': 137.16667}}, {'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'city': 'Ichikawa', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'city': 'Narita', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.78333, 'lon': 140.31667}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Chitose', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.81944, 'lon': 141.65222}}, {'city': 'Hakodate', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tomakomai', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.63694, 'lon': 141.60333}}, {'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Katō', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.92422, 'lon': 135.02609}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Hitachi', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 140.65}}, {'city': 'Hitachi-Naka', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.39659, 'lon': 140.53479}}, {'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Komatsu', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.40263, 'lon': 136.45088}}, {'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Kirishima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'geoPoint': {'lat': 31.74087, 'lon': 130.76288}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Tamana', 'state': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.94716, 'lon': 130.57446}}, {'city': 'Miyagi-gun', 'state': 'Miyagi', 'country': 'Japan'}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Hyūga', 'state': 'Miyazaki', 'country': 'Japan', 'geoPoint': {'lat': 32.42272, 'lon': 131.64093}}, {'city': 'Isahaya', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.84111, 'lon': 130.04306}}, {'city': 'Sasebo', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'city': 'Ikoma', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.68333, 'lon': 135.7}}, {'city': 'Higashiosaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.66667, 'lon': 135.58333}}, {'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'city': 'Hiki-gun', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Iruma', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.818, 'lon': 139.368}}, {'city': 'Kawaguchi', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.80521, 'lon': 139.71072}}, {'city': 'Tokorozawa', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'city': 'Matsue', 'state': 'Shimane', 'country': 'Japan', 'geoPoint': {'lat': 35.48333, 'lon': 133.05}}, {'city': 'Nasushiobara', 'state': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.97682, 'lon': 140.06642}}, {'city': 'Oyama', 'state': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.3, 'lon': 139.8}}, {'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Yoshinogawa', 'state': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.03858, 'lon': 134.29207}}, {'city': 'Chiyoda City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.68449, 'lon': 139.75056}}, {'city': 'Edogawa City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.69225, 'lon': 139.87308}}, {'city': 'Otaku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Setagaya City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.64188, 'lon': 139.64715}}, {'city': 'Sumida City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.73289, 'lon': 139.82085}}, {'city': 'Takaoka', 'state': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'city': 'Tonami', 'state': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.62047, 'lon': 136.94321}}, {'city': 'Yonezawa', 'state': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 37.91, 'lon': 140.11667}}, {'city': 'Hōfu', 'state': 'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 34.05, 'lon': 131.56667}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kagashima', 'country': 'Japan', 'geoPoint': {'lat': 35.4, 'lon': 136.71667}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}], 'overallOfficials': [{'name': 'Kota Nagai', 'role': 'STUDY_DIRECTOR', 'affiliation': 'JAC PCU. EPCS, Eisai Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'FUJIFILM Toyama Chemical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}