Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT01202760
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2010-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Rheumatoid Arthritis Study in Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Peru']}, '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': 'C575974', 'term': 'tabalumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '120 mg LY2127399, Randomized Treatment Period', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nDuring the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.\n\nThe Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders.', 'otherNumAtRisk': 379, 'otherNumAffected': 174, 'seriousNumAtRisk': 379, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': '90 mg LY2127399, Randomized Treatment Period', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nThe Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders.', 'otherNumAtRisk': 371, 'otherNumAffected': 154, 'seriousNumAtRisk': 371, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Placebo, Randomized Treatment Period', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nThe Randomized Treatment Period was defined as the time all data was collected during the Treatment Period, excluding the data collected after the date of the Week 16 injection for the Week 16 non-responders.', 'otherNumAtRisk': 250, 'otherNumAffected': 98, 'seriousNumAtRisk': 250, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': '120 mg LY2127399, Rescue Period', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nDuring the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.\n\nAfter 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.\n\nThe Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders.', 'otherNumAtRisk': 81, 'otherNumAffected': 23, 'seriousNumAtRisk': 81, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': '90 mg LY2127399, Rescue Period', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.\n\nThe Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders.', 'otherNumAtRisk': 72, 'otherNumAffected': 16, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo, Rescue Period', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.\n\nThe Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period for Week 16 non-responders.', 'otherNumAtRisk': 56, 'otherNumAffected': 9, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '120 mg LY2127399, Follow-up Period', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nDuring the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.\n\nThe Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 40, 'otherNumAffected': 12, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '90 mg LY2127399, Follow-up Period', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nThe Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 45, 'otherNumAffected': 17, 'seriousNumAtRisk': 45, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'Placebo, Follow-up Period', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nThe Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 37, 'otherNumAffected': 13, 'seriousNumAtRisk': 37, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': '120 mg LY2127399 to 90 mg LY212739 (Week 16), Follow-up Period', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nDuring the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks.\n\nAfter 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.\n\nThe Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Placebo to 90 mg LY2127399 (Week 16), Follow-up Period', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.\n\nThe Post-Treatment Follow-Up Period started after Week 24 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Mitral valve prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Macular pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 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'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 371, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}, {'value': '31.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': "ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \\>=20% improvement from baseline in both 68 tender and 66 swollen joint counts and \\>=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)\\*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable ACR20 data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'title': 'ACR50', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}, {'value': '12.7', 'groupId': 'OG002'}]}]}, {'title': 'ACR70', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '4.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had \\>=50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and \\>=50% improvement in at least 3/5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No) of ACR50 responders/No of Pts treated)\\*100. ACR70 Responder: had \\>=70% improvement from baseline in both TJ and SJ counts and \\>=70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response=(No of ACR70 responders/No of Pts treated)\\*100. All non-responders at Week 16 as well as all Pts who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with at least 5/68 TJ and 5/66 SJ at baseline and with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included."}, {'type': 'SECONDARY', 'title': 'Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.5', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '-11.5', 'spread': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in rheumatoid arthritis that characterizes percentage of improvement in disease activity from baseline based on ACR core set. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater percent improvement). This index was calculated as minimum of a) percentage of improvement in TJ count, b) percentage of improvement in SJ count, or c) third highest percentage of improvement of remaining 5 ACR core criteria: If \\>=3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment, region, tumor necrosis factor-inadequate responder treatment history, and disease-modifying anti-rheumatic drug (DMARD) background as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR-N data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.61', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-1.63', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '-2.11', 'spread': '1.40', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'joint count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable tender joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.59', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '-3.59', 'spread': '1.05', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'joint count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable swollen joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-6.9', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Participant's assessment of their current arthritis pain using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant's assessment of pain data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included."}, {'type': 'SECONDARY', 'title': "Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-6.9', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant's global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included."}, {'type': 'SECONDARY', 'title': "Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-9.7', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Physician's assessment of the participant's current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable physician's global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and participant global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56\\*square root (sqrt)(TJC28)+0.28\\*sqrt(SJC28)+0.36\\*natural log(CRP+1)+0.014\\*participant global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP \\<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, even if participant did not take assigned treatment, did not receive correct treatment, or otherwise did not follow protocol, with evaluable DAS28-CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '0.05', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \\[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable HAQ-DI data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Time to American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '20.1'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '20.1'}, {'value': '16.4', 'groupId': 'OG002', 'lowerLimit': '15.9', 'upperLimit': '23.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through 24 weeks', 'description': "ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \\>= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and \\>=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:\n\n(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.'}, {'type': 'SECONDARY', 'title': 'Probability of an ACR20 Response by 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.612', 'groupId': 'OG000'}, {'value': '0.611', 'groupId': 'OG001'}, {'value': '0.608', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks', 'description': "ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \\>= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and \\>=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:\n\n(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.", 'unitOfMeasure': 'probability of response', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000'}, {'value': '49.7', 'groupId': 'OG001'}, {'value': '46.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'EULAR Responder index based on 28 joint count categorizes clinical response based on improvement since baseline in DAS28-CRP. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR28 responder is defined as either DAS28-CRP \\<=5.1 and DAS28-CRP change \\<-0.6; or DAS28-CRP \\>5.1 and DAS28-CRP change \\<-1.2. EULAR28 responder index is defined as good response: DAS28-CRP \\<=3.2 and DAS28-CRP change \\<-1.2; moderate response: DAS28-CRP change \\<-1.2 except cases defined in good response; or DAS28-CRP \\<=5.1 and DAS28-CRP change \\<-0.6 and \\>-1.2. EULAR Remission is defined as a DAS28-CRP score of \\<2.6.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable EULAR response data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'title': 'Physical functioning domain', 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '3.14', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '1.48', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': 'Bodily pain domain', 'categories': [{'measurements': [{'value': '1.62', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '1.34', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'Role limitations due to physical problems domain', 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '2.40', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': 'Role limitations due to emotional problems domain', 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '3.11', 'spread': '1.09', 'groupId': 'OG002'}]}]}, {'title': 'General health perception domain', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '1.81', 'spread': '0.82', 'groupId': 'OG002'}]}]}, {'title': 'Mental health domain', 'categories': [{'measurements': [{'value': '3.09', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '0.97', 'groupId': 'OG002'}]}]}, {'title': 'Social function domain', 'categories': [{'measurements': [{'value': '1.17', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '1.08', 'groupId': 'OG002'}]}]}, {'title': 'Vitality domain', 'categories': [{'measurements': [{'value': '2.85', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '2.22', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': 'Physical component summary score', 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '0.85', 'groupId': 'OG002'}]}]}, {'title': 'Mental component summary score', 'categories': [{'measurements': [{'value': '3.18', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '2.54', 'spread': '1.03', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \\[MCS\\] and physical health \\[PCS\\]). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable SF-36 domain and summary scores. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.69', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '1.76', 'spread': '1.54', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.5', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '-74.4', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '20.9', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B-cell count is determined by calculating the average of the 2 pretreatment B-cell counts obtained once during Days -28 through -7 and on Day 0. A positive or negative change indicated an increase or decrease, respectively in B-cell count. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'cells per microliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study treatment with evaluable absolute B-cell data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}], 'classes': [{'title': 'Immunoglobulin G', 'categories': [{'measurements': [{'value': '-0.813', 'spread': '0.165', 'groupId': 'OG000'}, {'value': '-0.758', 'spread': '0.165', 'groupId': 'OG001'}, {'value': '0.117', 'spread': '0.178', 'groupId': 'OG002'}]}]}, {'title': 'Immunoglobulin A', 'categories': [{'measurements': [{'value': '-0.209', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.224', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '0.139', 'spread': '0.047', 'groupId': 'OG002'}]}]}, {'title': 'Immunoglobulin M', 'categories': [{'measurements': [{'value': '-0.267', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '-0.275', 'spread': '0.025', 'groupId': 'OG001'}, {'value': '-0.049', 'spread': '0.028', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in immunoglobulin levels. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study treatment with evaluable serum immunoglobulin (Ig) data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values.'}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics (PK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '777', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2127399', 'description': '120 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\n90 milligrams (mg) LY2127399: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.60', 'spread': '2.54', 'groupId': 'OG000', 'lowerLimit': '3.44', 'upperLimit': '3.78'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 24 weeks', 'description': 'Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.', 'unitOfMeasure': 'milliliter per hour (mL/h)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Developing Anti-LY2127399 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240 mg (2 SC injections of 120 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180 mg (2 SC injections of 90 mg each) loading dose when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks', 'description': 'LY2127399 anti-drug antibodies (ADA) were assessed at baseline, 1, 4, 16, and 24 weeks. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)\\*100. Pts with treatment-emergent ADA were Pts who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or Pts who tested negative at baseline and positive post-baseline (at titer of ≥1:20).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.\n\nDuring the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.\n\nAfter 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'FG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '374'}, {'groupId': 'FG002', 'numSubjects': '251'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '371'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '332'}, {'groupId': 'FG001', 'numSubjects': '322'}, {'groupId': 'FG002', 'numSubjects': '216'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Parent / Caregiver Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '1004', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.\n\nDuring the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.\n\nAfter 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'BG001', 'title': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '50.6', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '51.4', 'spread': '11.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '797', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '511', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '651', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '334', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Sri Lanka', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tender Joint Count (68 Count)', 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '23.7', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '22.8', 'spread': '15.2', 'groupId': 'BG002'}, {'value': '23.2', 'spread': '16.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.', 'unitOfMeasure': 'joint count', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Swollen Joint Count (66 Count)', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '15.3', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '14.8', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.', 'unitOfMeasure': 'joint count', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants, including participants who did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1004}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2013-04-30', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-24', 'studyFirstSubmitDate': '2010-09-14', 'dispFirstSubmitQcDate': '2013-04-30', 'resultsFirstSubmitDate': '2018-03-24', 'studyFirstSubmitQcDate': '2010-09-14', 'dispFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-24', 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology 20% (ACR20) Response', 'timeFrame': 'Up to 24 weeks', 'description': "ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \\>=20% improvement from baseline in both 68 tender and 66 swollen joint counts and \\>=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)\\*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses', 'timeFrame': 'Up to 24 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had \\>=50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and \\>=50% improvement in at least 3/5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No) of ACR50 responders/No of Pts treated)\\*100. ACR70 Responder: had \\>=70% improvement from baseline in both TJ and SJ counts and \\>=70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response=(No of ACR70 responders/No of Pts treated)\\*100. All non-responders at Week 16 as well as all Pts who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint."}, {'measure': 'Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)', 'timeFrame': 'Up to 24 weeks', 'description': 'ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in rheumatoid arthritis that characterizes percentage of improvement in disease activity from baseline based on ACR core set. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater percent improvement). This index was calculated as minimum of a) percentage of improvement in TJ count, b) percentage of improvement in SJ count, or c) third highest percentage of improvement of remaining 5 ACR core criteria: If \\>=3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment, region, tumor necrosis factor-inadequate responder treatment history, and disease-modifying anti-rheumatic drug (DMARD) background as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.'}, {'measure': "Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)", 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Participant's assessment of their current arthritis pain using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate."}, {'measure': "Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)", 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate."}, {'measure': "Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)", 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Physician's assessment of the participant's current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and participant global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56\\*square root (sqrt)(TJC28)+0.28\\*sqrt(SJC28)+0.36\\*natural log(CRP+1)+0.014\\*participant global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP \\<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \\[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate."}, {'measure': 'Time to American College of Rheumatology 20% (ACR20) Response', 'timeFrame': 'Baseline through 24 weeks', 'description': "ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \\>= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and \\>=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:\n\n(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7."}, {'measure': 'Probability of an ACR20 Response by 24 Weeks', 'timeFrame': 'Baseline through 24 weeks', 'description': "ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \\>= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and \\>=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:\n\n(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7."}, {'measure': 'Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response', 'timeFrame': 'Up to 24 weeks', 'description': 'EULAR Responder index based on 28 joint count categorizes clinical response based on improvement since baseline in DAS28-CRP. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR28 responder is defined as either DAS28-CRP \\<=5.1 and DAS28-CRP change \\<-0.6; or DAS28-CRP \\>5.1 and DAS28-CRP change \\<-1.2. EULAR28 responder index is defined as good response: DAS28-CRP \\<=3.2 and DAS28-CRP change \\<-1.2; moderate response: DAS28-CRP change \\<-1.2 except cases defined in good response; or DAS28-CRP \\<=5.1 and DAS28-CRP change \\<-0.6 and \\>-1.2. EULAR Remission is defined as a DAS28-CRP score of \\<2.6.'}, {'measure': 'Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \\[MCS\\] and physical health \\[PCS\\]). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint', 'timeFrame': 'Baseline, up to 24 weeks', 'description': "CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B-cell count is determined by calculating the average of the 2 pretreatment B-cell counts obtained once during Days -28 through -7 and on Day 0. A positive or negative change indicated an increase or decrease, respectively in B-cell count. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels', 'timeFrame': 'Baseline, up to 24 weeks', 'description': 'Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in immunoglobulin levels. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.'}, {'measure': 'Population Pharmacokinetics (PK)', 'timeFrame': 'Baseline through 24 weeks', 'description': 'Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.'}, {'measure': 'Percentage of Participants Developing Anti-LY2127399 Antibodies', 'timeFrame': 'Baseline through 24 weeks', 'description': 'LY2127399 anti-drug antibodies (ADA) were assessed at baseline, 1, 4, 16, and 24 weeks. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)\\*100. Pts with treatment-emergent ADA were Pts who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or Pts who tested negative at baseline and positive post-baseline (at titer of ≥1:20).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy.\n\nThis study is comprised of 2 periods:\n\nPeriod 1 - 24-week blinded treatment\n\nPeriod 2 - 48-week post-treatment follow-up', 'detailedDescription': 'In consideration of disease severity, all participants were assessed for non-response at Week 16. A total of 66 joints were examined for swelling, and a total of 66 joint were examined for tenderness. For participants who had at least 5 swollen and 5 tender joints at baseline, Week 16 non-responders (NRs) were defined as participants with \\<20% improvement from baseline in both tender joint counts and swollen joint counts. For participants who did not have at least 5 swollen and 5 tender joints at baseline, Week 16 NRs were defined as participants who had at least 2 additional tender and 2 additional swollen joints from baseline. All Week 16 NRs and all participants who discontinued study treatment at any time, for any reason, were defined as NRs starting at that timepoint and going forward for all American College of Rheumatology (ACR) imputed analyses, including the Week 24 endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years\n* Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)\n* If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.\n* Women must not be pregnant, breastfeeding, or become pregnant during the study\n\nExclusion Criteria:\n\n* Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks\n* Steroid injection or intravenous (IV) infusion in the last 6 weeks\n* Use of more than 10 milligrams per day (mg/day) of oral steroids in the last 6 weeks\n* Use of biologic DMARD concurrently or recently\n* History of a serious reaction to other biological DMARDs\n* Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks\n* Surgery on a joint or other major surgery less than 2 months prior to study start, or plans to have joint surgery or major surgery during the study\n* Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA\n* Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years\n* Received a live vaccine within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)\n* Hepatitis or human immunodeficiency virus (HIV)\n* A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months\n* Symptoms of herpes zoster or herpes simplex within the last month\n* Active or latent tuberculosis (TB)\n* Current symptoms of a serious disorder or illness\n* Use of an investigational drug within the last month"}, 'identificationModule': {'nctId': 'NCT01202760', 'acronym': 'FLEX O', 'briefTitle': 'A Rheumatoid Arthritis Study in Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)', 'orgStudyIdInfo': {'id': '12978'}, 'secondaryIdInfos': [{'id': 'H9B-MC-BCDO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'CTRI/2011/07/001867', 'type': 'REGISTRY', 'domain': 'Clinical Trials Registry India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '120 mg LY2127399', 'description': 'LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.\n\nDuring the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.\n\nAfter 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.', 'interventionNames': ['Drug: LY2127399', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '90 mg LY2127399', 'description': 'LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.\n\nAfter 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.', 'interventionNames': ['Drug: LY2127399']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.\n\nAfter 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.', 'interventionNames': ['Drug: LY2127399', 'Drug: Placebo']}], 'interventions': [{'name': 'LY2127399', 'type': 'DRUG', 'otherNames': ['Tabalumab'], 'armGroupLabels': ['120 mg LY2127399', '90 mg LY2127399', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['120 mg LY2127399', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85253', 'city': 'Paradise Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.53115, 'lon': -111.94265}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '90606', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '92595', 'city': 'Wildomar', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.59891, 'lon': -117.28004}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '32713', 'city': 'DeBary', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.88305, 'lon': -81.30868}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '33716', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '34292', 'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'zip': '33542', 'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '30045', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '83616', 'city': 'Eagle', 'state': 'Idaho', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.69544, 'lon': -116.35401}}, {'zip': '60053', 'city': 'Morton Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.04059, 'lon': -87.78256}}, {'zip': '61103', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21502', 'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'zip': '02601', 'city': 'Hyannis', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.65289, 'lon': -70.2828}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48025', 'city': 'Bingham Farms', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}, {'zip': '48081', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '77058', 'city': 'Nassau Bay', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.54468, 'lon': -95.09104}}, {'zip': '76180', 'city': 'North Richland Hills', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.8343, 'lon': -97.2289}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9000', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '51410', 'city': 'Opatija', 'country': 'Croatia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.33658, 'lon': 14.30782}}, {'zip': 'HR-51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '21000', 'city': 'Split', 'country': 'Croatia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '6400', 'city': 'Kiskunhalas', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.43402, 'lon': 19.48479}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '3980', 'city': 'Sátoraljaújhely', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.39492, 'lon': 21.65871}}, {'zip': '3800', 'city': 'Szikszó', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.2, 'lon': 20.93333}}, {'zip': '8200', 'city': 'Veszprém', 'country': 'Hungary', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '3800015', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '5600092', 'city': 'Bangalore', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '600100', 'city': 'Chennai', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '500033', 'city': 'Hyderabaad', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '302023', 'city': 'Jaipur', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '570023', 'city': 'Mysore', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '524003', 'city': 'Nellore', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 14.44992, 'lon': 79.98697}}, {'zip': '110 076', 'city': 'New Delhi', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '500 003', 'city': 'Secunderabad', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 17.50427, 'lon': 78.54263}}, {'zip': '560092', 'city': 'Surat', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '460-0001', 'city': 'Aichi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '820-8505', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '370-0053', 'city': 'Gunma', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '063-0811', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '650-0017', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '316-0035', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '252-0392', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '861-8520', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '514-1101', 'city': 'Mie', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.96667, 'lon': 131.58333}}, {'zip': '982-0032', 'city': 'Miyagi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'zip': '390-8601', 'city': 'Nagano', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '857-1195', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '634-0007', 'city': 'Nara', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'zip': '874-0011', 'city': 'Ohita', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '712-8044', 'city': 'Okayama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '586-8521', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '843-0393', 'city': 'Saga', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '337-0012', 'city': 'Saitama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '060-8648', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '420-8623', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '185-0012', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '053-8567', 'city': 'Tomakomai', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.63694, 'lon': 141.60333}}, {'zip': '62114', 'city': 'Alytus', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.39574, 'lon': 24.03885}}, {'zip': '49475', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '92288', 'city': 'Klaipedos', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '73231', 'city': 'Šiauliai', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.93333, 'lon': 23.31667}}, {'zip': 'LT-08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '68100', 'city': 'Batu Caves', 'country': 'Malaysia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 3.238, 'lon': 101.682}}, {'zip': '25100', 'city': 'Kuantan Pahang', 'country': 'Malaysia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '30990', 'city': 'Perak', 'country': 'Malaysia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 3.8682, 'lon': 102.5862}}, {'zip': '93586', 'city': 'Sarawak', 'country': 'Malaysia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '20203', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '31000', 'city': 'Chihuahua City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '44690', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '21100', 'city': 'Mexicali', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.62781, 'lon': -115.45446}}, {'zip': '06100', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64000', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '58070', 'city': 'Morelia', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}, {'zip': '76000', 'city': 'Querétaro', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 15.83752, 'lon': -92.75774}}, {'zip': '78200', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '22010', 'city': 'Tijuana', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}, {'zip': '14080', 'city': 'Tlalpan', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}, {'zip': '3204', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '3010', 'city': 'Rotorua', 'country': 'New Zealand', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -38.13874, 'lon': 176.24516}}, {'zip': '3140', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'city': 'Timaru', 'country': 'New Zealand', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -44.39672, 'lon': 171.25364}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '81-384', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '134-727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Colombo', 'country': 'Sri Lanka', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '49008', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83045', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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