Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-01-12 @ 12:58 PM
Study NCT ID:
NCT01198002
Status:
TERMINATED
Last Update Posted:
2018-05-08
First Post:
2010-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate
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'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study has been terminated not based on safety concerns, but due to insufficient efficacy. Early termination led to lower than expected enrollment and was responsible for the large number of discontinuation reason as Sponsor Decision.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LY 120 mg Q4W, Randomized Treatment Period 1', 'description': 'A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nThe Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.', 'otherNumAtRisk': 345, 'otherNumAffected': 137, 'seriousNumAtRisk': 345, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'LY 90 mg Q2W, Randomized Treatment Period 1', 'description': 'A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nThe Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.', 'otherNumAtRisk': 345, 'otherNumAffected': 117, 'seriousNumAtRisk': 345, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Placebo, Randomized Treatment Period 1', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nThe Randomized Treatment Period 1 was defined as the time all data was collected during the Treatment Period 1, excluding the data collected after the date of the Week 16 injection for the Week 16 NR.', 'otherNumAtRisk': 348, 'otherNumAffected': 129, 'seriousNumAtRisk': 348, 'seriousNumAffected': 17}, {'id': 'EG003', 'title': 'LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Rescue Period', 'description': 'A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.\n\nThe Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR.', 'otherNumAtRisk': 58, 'otherNumAffected': 22, 'seriousNumAtRisk': 58, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'LY 90 mg Q2W, Rescue Period', 'description': 'A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 16 weeks during Treatment Period 1.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.\n\nThe Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR.', 'otherNumAtRisk': 62, 'otherNumAffected': 25, 'seriousNumAtRisk': 62, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Placebo to LY 90 mg Q2W (Week 16), Rescue Period', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.\n\nThe Rescue Treatment Period was defined as all data collected after the date of the Week 16 injection during the Treatment Period 1 for Week 16 NR.', 'otherNumAtRisk': 90, 'otherNumAffected': 20, 'seriousNumAtRisk': 90, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'LY 120 mg Q4W, Treatment Period 2', 'description': 'A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nTreatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.', 'otherNumAtRisk': 57, 'otherNumAffected': 22, 'seriousNumAtRisk': 57, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'LY 90 mg Q2W, Treatment Period 2', 'description': 'A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nAt Week 52, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nTreatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.', 'otherNumAtRisk': 73, 'otherNumAffected': 20, 'seriousNumAtRisk': 73, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nAt Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2\n\nTreatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.', 'otherNumAtRisk': 27, 'otherNumAffected': 7, 'seriousNumAtRisk': 27, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nAt Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2\n\nTreatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.', 'otherNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2', 'description': 'A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, Week 16 NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.\n\nDuring non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.\n\nTreatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.', 'otherNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.\n\nAt Week 16, Week 16 NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.\n\nDuring non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.\n\nTreatment Period 2 was defined as all data collected from Week 52 to Week 100 during non-blinded Treatment Period 2.', 'otherNumAtRisk': 22, 'otherNumAffected': 9, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'LY 120 mg Q4W, Follow-up Period', 'description': 'A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 52-week Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nThe Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 241, 'otherNumAffected': 43, 'seriousNumAtRisk': 241, 'seriousNumAffected': 9}, {'id': 'EG013', 'title': 'LY 90 mg Q2W, Follow-up Period', 'description': 'A loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nAt Week 52, both Week 16 responders and NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nThe Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 303, 'otherNumAffected': 39, 'seriousNumAtRisk': 303, 'seriousNumAffected': 14}, {'id': 'EG014', 'title': 'Placebo to LY 120 mg Q4W (Week 52), Follow-up Period', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nAt Week 52, Week 16 responders were randomized to receive 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2\n\nThe Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 27, 'otherNumAffected': 6, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}, {'id': 'EG015', 'title': 'Placebo to LY 90 mg Q2W (Week 52), Follow-up Period', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, Week 16 responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nAt Week 52, Week 16 responders were randomized to receive 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q4W for the rest of the Treatment Period 2\n\nThe Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 27, 'otherNumAffected': 9, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}, {'id': 'EG016', 'title': 'LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period', 'description': 'A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, Week 16 NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.\n\nDuring non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.\n\nThe Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 52, 'otherNumAffected': 10, 'seriousNumAtRisk': 52, 'seriousNumAffected': 5}, {'id': 'EG017', 'title': 'Placebo to LY 90 mg Q2W (Week 16), Follow-up Period', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 16 weeks during Treatment Period 1.\n\nAt Week 16, Week 16 NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.\n\nDuring non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.\n\nThe Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 85, 'otherNumAffected': 10, 'seriousNumAtRisk': 85, 'seriousNumAffected': 4}, {'id': 'EG018', 'title': 'Placebo, Follow-up Period', 'description': 'A loading dose of 2 injections of placebo followed by maintenance dosing of placebo administered SC Q2W for 52 weeks during Treatment Period 1. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nThe Post-Treatment Follow-Up Period started after Week 52 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.', 'otherNumAtRisk': 168, 'otherNumAffected': 26, 'seriousNumAtRisk': 168, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 348, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 348, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 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'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '32.8', 'groupId': 'OG001'}, {'value': '25.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). 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 NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included."}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '1.57', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 52 Weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 \\[normal\\] to 388 \\[maximal disease\\]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.03', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 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 were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable HAQ-DI data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'ACR50 - Week 24', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'ACR50 - Week 52', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 - Week 24', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '3.0', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 - Week 52', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks and 52 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA. 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 of 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 NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.78', 'spread': '0.07', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 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), CRP \\[milligrams per liter (mg/L)\\], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). 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 from 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 and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable DAS28-CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24- Good', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '16.2', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - Moderate', 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}, {'value': '30.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 - No Response', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '45.3', 'groupId': 'OG001'}, {'value': '54.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 - Good', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 - Moderate', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}, {'value': '29.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 - No Response', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}, {'value': '55.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks and 52 weeks', 'description': 'EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP \\>5.1, low disease activity: DAS28-CRP \\<3.2, and remission: DAS28-CRP \\<2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: \\<3.2 or \\>1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: \\>5.1 or \\<0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) \\* 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable EULAR response data. Modified last observation carried forward (mLOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Physical functioning - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.70', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '2.06', 'spread': '0.47', 'groupId': 'OG002'}]}]}, {'title': 'Physical functioning - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '3.22', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '1.82', 'spread': '0.49', 'groupId': 'OG002'}]}]}, {'title': 'Bodily pain - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.07', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '2.52', 'spread': '0.45', 'groupId': 'OG002'}]}]}, {'title': 'Bodily pain - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.77', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '2.32', 'spread': '0.46', 'groupId': 'OG002'}]}]}, {'title': 'RL - physical problems - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.77', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '1.99', 'spread': '0.45', 'groupId': 'OG002'}]}]}, {'title': 'RL - physical problems - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.01', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '3.79', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '1.82', 'spread': '0.46', 'groupId': 'OG002'}]}]}, {'title': 'RL - emotional problems- Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.20', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '4.81', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '2.91', 'spread': '0.59', 'groupId': 'OG002'}]}]}, {'title': 'RL - emotional problems- Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.84', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '2.56', 'spread': '0.59', 'groupId': 'OG002'}]}]}, {'title': 'GH Perception - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '2.54', 'spread': '0.40', 'groupId': 'OG002'}]}]}, {'title': 'GH Perception - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.89', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '2.18', 'spread': '0.41', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.39', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '4.47', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '3.28', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.01', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '3.10', 'spread': '0.54', 'groupId': 'OG002'}]}]}, {'title': 'Social function - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '2.79', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Social function - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.04', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '2.87', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Vitality - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '4.41', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '2.99', 'spread': '0.48', 'groupId': 'OG002'}]}]}, {'title': 'Vitality - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.10', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '3.02', 'spread': '0.49', 'groupId': 'OG002'}]}]}, {'title': 'PCS - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.80', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '1.76', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'PCS - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.79', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '1.55', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'MCS - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.34', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '4.74', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '0.55', 'groupId': 'OG002'}]}]}, {'title': 'MCS - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.98', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '3.22', 'spread': '0.56', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "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, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If \\< 50% of the questions within a domain were answered, raw scores were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100. Higher score indicated better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable SF-36 domain and summary scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Fatigue-Now - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue-Now - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.56', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue-Usual - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue-Usual - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.66', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue-Worst - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.98', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue-Worst - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.22', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.81', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'General Activity - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'General Activity - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Mood - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Mood - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Walking Ability - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Walking Ability - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Normal Work - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Normal Work - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.52', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Relations with Other - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Relations with Other - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Enjoyment of Life - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Enjoyment of Life - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.14', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue Impact Subscale- Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue Impact Subscale- Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable BFI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duration of Morning Stiffness (Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-41.2', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-32.0', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '-34.5', 'spread': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-41.4', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-31.2', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '-37.3', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': 'The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable morning stiffness data; mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Pain-Worst - Week 24', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Worst - Week 52', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Least - Week 24', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Least - Week 52', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Average - Week 24', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Average - Week 52', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Now - Week 24', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain-Now - Week 52', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'General Activity - Week 24', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'General Activity - Week 52', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Mood - Week 24', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Mood - Week 52', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Walking Ability - Week 24', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Walking Ability - Week 52', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Normal Work - Week 24', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Normal Work - Week 52', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Relations with Other - Week 24', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Relations with Other - Week 52', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Sleep - Week 24', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Sleep - Week 52', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Enjoyment of Life - Week 24', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Enjoyment of Life - Week 52', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain Interference Score - Week 24', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Pain Interference Score - Week 52', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': 'The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life \\[each item scored from 0 (does not interfere) to 10 (completely interferes)\\]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable BPI-SF scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'timeFrame': 'Baseline through 52 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Per protocol and statistical analysis plan (SAP) amendments, the major clinical response classification was not collected for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '61.8', 'groupId': 'OG001'}, {'value': '56.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 \\[normal\\] to 388 \\[maximal disease\\]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) \\* 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in B Cell Subset Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'CD19+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-57.1', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-60.9', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'CD19+IgD-CD27-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'CD19+IgD+CD27-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-89.4', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-92.4', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'CD19+IgD+CD27+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'CD19+IgD-CD27+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 52 weeks', 'description': 'B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional \\[CD19+immunoglobulin D (IgD)-CD27-\\], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'cells/microliter (cells/µL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable B cell subset counts data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics (PK): Constant Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '825', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2127399', 'description': 'A loading dose of 240 mg (2 injections of 120 mg) of LY2127399 followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 100 weeks or a loading dose of 180 mg of LY2127399 (2 injections of 90 mg) followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W for 100 weeks. At Weeks 16 and 52, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period or 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.60', 'groupId': 'OG000', 'lowerLimit': '3.46', 'upperLimit': '3.73'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.', 'unitOfMeasure': 'milliliter per hour (mL/h)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized 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': '344', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Participants with treatment-emergent anti-drug antibodies (ADA) were participants 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 participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) \\* 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result. Participants missing an evaluable baseline result with all negative post-baseline results were included. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With No Structural Progression at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '57.6', 'groupId': 'OG001'}, {'value': '53.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': 'No structural progression is defined as the change in mTSS from baseline ≤0. The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 \\[normal\\] to 388 \\[maximal disease\\]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) \\* 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in mTSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.82', 'spread': '0.14', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 \\[normal\\] to 388 \\[maximal disease\\]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Immunoglobulin (Ig) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'IgA', 'categories': [{'measurements': [{'value': '-0.380', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '-0.382', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '-0.009', 'spread': '0.028', 'groupId': 'OG002'}]}]}, {'title': 'IgG', 'categories': [{'measurements': [{'value': '-1.375', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '-1.235', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '-0.176', 'spread': '0.096', 'groupId': 'OG002'}]}]}, {'title': 'IgM', 'categories': [{'measurements': [{'value': '-0.235', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '-0.274', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '-0.032', 'spread': '0.016', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 52 weeks', 'description': 'Immunoglobulins (Ig), 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 Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'grams/liter (g/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable serum Ig data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'title': 'Joint Space Narrowing - Week 24', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.09', 'groupId': 'OG002'}]}]}, {'title': 'Joint Space Narrowing - Week 52', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Bone Erosions - Week 24', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Bone Erosions - Week 52', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 \\[normal\\] to 388 \\[maximal disease\\]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology Percent Improvement (ACR-N)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-6.9', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-7.3', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 24 weeks and 52 weeks', 'description': 'ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change 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. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.', 'unitOfMeasure': 'percentage of improvement', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable ACR-N data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count (68 Joint Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-7.41', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-7.88', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '-6.40', 'spread': '0.72', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-7.88', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-8.09', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-5.72', 'spread': '0.73', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 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 was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'joint counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable tender joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count (66 Joint Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-5.38', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-5.64', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-4.67', 'spread': '0.49', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-6.10', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-5.53', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-4.61', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 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 and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'joint counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable swollen joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]", 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-13.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-9.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-13.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-8.7', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "Participant's assessment of their current arthritis pain using 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 and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with evaluable participant's assessment of pain data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included."}, {'type': 'SECONDARY', 'title': "Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-13.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-13.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-15.2', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-10.8', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "Participant's assessment of their current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with evaluable participant's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included."}, {'type': 'SECONDARY', 'title': "Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-20.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-22.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-17.2', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-20.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-20.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-17.8', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with evaluable physician's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in HAQ-DI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.03', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 52 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 were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable HAQ-DI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Absolute B Cell Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-56.5', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '-58.6', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '4.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 52 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. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.', 'unitOfMeasure': 'cells/microliter (cells/µL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable CD3-CD20+ B cell counts. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR20 at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). 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, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders) /( number of participants treated) \\* 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 52 endpoint.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included."}, {'type': 'SECONDARY', 'title': 'Time to ACR20 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '16.4'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '20.0'}, {'value': '20.1', 'groupId': 'OG002', 'lowerLimit': '16.4', 'upperLimit': '24.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through 52 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). 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, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable ACR20 responder data. The number of participants censored are 128 (120 mg LY2127399), 123 (90 mg LY2127399) and 162 (placebo).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-3.30', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-2.03', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '-0.54', 'spread': '0.83', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-1.72', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-2.04', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.96', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks and 52 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 and region as fixed factors and baseline as a covariate.", 'unitOfMeasure': 'milligrams/liter (mg/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Died During Post-Treatment Follow-Up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Discontinuation from study treatment up to 48 weeks during follow-up period', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and entered post-treatment follow-up period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W).\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'FG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}], 'periods': [{'title': 'Treatment Period 1 (Weeks 0-52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '345'}, {'groupId': 'FG001', 'numSubjects': '347'}, {'groupId': 'FG002', 'numSubjects': '349'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '345'}, {'groupId': 'FG001', 'numSubjects': '345'}, {'groupId': 'FG002', 'numSubjects': '348'}]}, {'type': 'Week 16 NR', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'Post-Treatment Follow-Up Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}, {'groupId': 'FG001', 'numSubjects': '303'}, {'groupId': 'FG002', 'numSubjects': '307'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Those who completed 52-week Treatment Period 1 including both Week 16 responders and NR.', 'groupId': 'FG000', 'numSubjects': '70'}, {'comment': 'Those who completed 52-week Treatment Period 1 including both Week 16 responders and NR.', 'groupId': 'FG001', 'numSubjects': '73'}, {'comment': 'Those who completed 52-week Treatment Period 1 including both Week 16 responders and NR.', 'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '274'}, {'groupId': 'FG002', 'numSubjects': '269'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '224'}]}]}, {'title': 'Treatment Period 2 (Weeks 52-100)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '75'}]}]}], 'preAssignmentDetails': 'Study had a blinded Treatment Period 1 (Weeks 0-52), a non-blinded Treatment Period 2 (Weeks 52-100) and a post-treatment follow-up (24-48 weeks in length). All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with \\<20% improvement from baseline in both tender and swollen joint counts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'BG000'}, {'value': '347', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '1041', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '120 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 240 mg (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.\n\nAt Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'BG001', 'title': '90 mg LY2127399', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W.\n\nAt Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W.\n\nAt Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1.\n\nTreatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.\n\nAt Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '52.9', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '53.2', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}, {'value': '877', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '411', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '439', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '588', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}, {'title': 'Sri Lanka', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1041}}, 'statusModule': {'whyStopped': 'Terminated not based on safety concerns, but due to insufficient efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'dispFirstSubmitDate': '2013-04-30', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2010-09-08', 'dispFirstSubmitQcDate': '2013-04-30', 'resultsFirstSubmitDate': '2018-03-24', 'studyFirstSubmitQcDate': '2010-09-08', 'dispFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-04', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Who Died During Post-Treatment Follow-Up Period', 'timeFrame': 'Discontinuation from study treatment up to 48 weeks during follow-up period'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24', 'timeFrame': 'Baseline through 24 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). 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 NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint."}, {'measure': 'Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)', 'timeFrame': 'Baseline, 52 Weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 \\[normal\\] to 388 \\[maximal disease\\]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)', 'timeFrame': 'Baseline, 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 were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response', 'timeFrame': 'Baseline through 24 weeks and 52 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA. 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 of 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 NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints."}, {'measure': 'Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)', 'timeFrame': 'Baseline, 24 weeks and 52 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), CRP \\[milligrams per liter (mg/L)\\], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). 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 from 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 and region as fixed factors and baseline as a covariate."}, {'measure': 'Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response', 'timeFrame': 'Baseline through 24 weeks and 52 weeks', 'description': 'EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP \\>5.1, low disease activity: DAS28-CRP \\<3.2, and remission: DAS28-CRP \\<2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: \\<3.2 or \\>1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: \\>5.1 or \\<0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) \\* 100.'}, {'measure': 'Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "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, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If \\< 50% of the questions within a domain were answered, raw scores were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100. Higher score indicated better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline in Duration of Morning Stiffness (Minutes)', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': 'The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': 'The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life \\[each item scored from 0 (does not interfere) to 10 (completely interferes)\\]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks', 'timeFrame': 'Baseline through 52 weeks'}, {'measure': 'Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0', 'timeFrame': 'Baseline through 24 weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 \\[normal\\] to 388 \\[maximal disease\\]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) \\* 100.'}, {'measure': 'Change From Baseline to Week 52 in B Cell Subset Counts', 'timeFrame': 'Baseline, 52 weeks', 'description': 'B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional \\[CD19+immunoglobulin D (IgD)-CD27-\\], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Population Pharmacokinetics (PK): Constant Clearance', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.'}, {'measure': 'Percentage of Participants Developing Anti-LY2127399 Antibodies', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Participants with treatment-emergent anti-drug antibodies (ADA) were participants 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 participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) \\* 100.'}, {'measure': 'Percentage of Participants With No Structural Progression at Week 52', 'timeFrame': 'Baseline through 52 weeks', 'description': 'No structural progression is defined as the change in mTSS from baseline ≤0. The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 \\[normal\\] to 388 \\[maximal disease\\]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) \\* 100.'}, {'measure': 'Change From Baseline to Week 24 in mTSS', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 \\[normal\\] to 388 \\[maximal disease\\]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline in Serum Immunoglobulin (Ig) Levels', 'timeFrame': 'Baseline, 52 weeks', 'description': 'Immunoglobulins (Ig), 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 Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)', 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': 'The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 \\[normal\\] to 388 \\[maximal disease\\]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'American College of Rheumatology Percent Improvement (ACR-N)', 'timeFrame': 'Baseline through 24 weeks and 52 weeks', 'description': 'ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change 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. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.'}, {'measure': 'Change From Baseline in Tender Joint Count (68 Joint Count)', 'timeFrame': 'Baseline, 24 weeks and 52 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 was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Change From Baseline in Swollen Joint Count (66 Joint Count)', 'timeFrame': 'Baseline, 24 weeks and 52 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 and region as fixed factors and baseline as a covariate.'}, {'measure': "Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]", 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "Participant's assessment of their current arthritis pain using 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 and region as fixed factors and baseline as a covariate."}, {'measure': "Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)", 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "Participant's assessment of their current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate."}, {'measure': "Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)", 'timeFrame': 'Baseline, 24 weeks and 52 weeks', 'description': "Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 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 and region as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline to Week 52 in HAQ-DI', 'timeFrame': 'Baseline, 52 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 were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate."}, {'measure': 'Change From Baseline to Week 52 in Absolute B Cell Counts', 'timeFrame': 'Baseline, 52 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. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.'}, {'measure': 'Percentage of Participants With ACR20 at Week 52', 'timeFrame': 'Baseline through 52 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). 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, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders) /( number of participants treated) \\* 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 52 endpoint."}, {'measure': 'Time to ACR20 Response', 'timeFrame': 'Baseline through 52 weeks', 'description': "ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). 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, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit."}, {'measure': 'Change From Baseline in CRP', 'timeFrame': 'Baseline, 24 weeks and 52 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 and region as fixed factors and baseline as a covariate."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '25873635', 'type': 'DERIVED', 'citation': 'Smolen JS, Weinblatt ME, van der Heijde D, Rigby WF, van Vollenhoven R, Bingham CO 3rd, Veenhuizen M, Gill A, Zhao F, Komocsar WJ, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study. Ann Rheum Dis. 2015 Aug;74(8):1567-70. doi: 10.1136/annrheumdis-2014-207090. Epub 2015 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.\n\nThis study is comprised of 3 periods:\n\nPeriod 1: 52-week blinded treatment\n\nPeriod 2: additional 48-week unblinded treatment\n\nPeriod 3: 48-week post-treatment follow-up'}, '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* Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks\n* At least 8 tender and swollen joints\n* At least one erosion of a hand or foot joint observed on an X-ray\n* An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)\n* Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody\n* Woman must not be pregnant, breastfeeding, or become pregnant during the study\n\nExclusion Criteria:\n\n* Use of unstable doses of non-steroidal anti-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/day (mg/day) of oral steroids in the last 6 weeks\n* History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)\n* History of a serious reaction to other biological DMARDs\n* History of the use of rituximab or other B cell therapy\n* Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks\n* Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)\n* Surgery on a joint or other major surgery less than 2 months ago, 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 received 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\n* History of the use of rituximab, any other B cell targeted biotherapy, or denosumab"}, 'identificationModule': {'nctId': 'NCT01198002', 'acronym': 'FLEX M', 'briefTitle': 'A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)', 'orgStudyIdInfo': {'id': '11352'}, 'secondaryIdInfos': [{'id': 'H9B-MC-BCDM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'CTRI/2011/07/001870', 'type': 'REGISTRY', 'domain': 'Clinical Trials Registry India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '120 milligrams (mg) LY2127399', 'description': 'Given every 4 weeks (Q4W) for 100 weeks. Participants receive a 240 mg loading dose when initiating treatment. During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W).\n\nAt Weeks 16 and 52, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period.\n\nAt Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.', 'interventionNames': ['Drug: LY2127399', 'Drug: Placebo Q4W', 'Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': '90 mg LY2127399', 'description': 'Given Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment.\n\nAt Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period.\n\nAt Week 16, NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.', 'interventionNames': ['Drug: LY2127399', 'Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Given Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks.\n\nAt Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.\n\nAt Week 16, NR will receive a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.', 'interventionNames': ['Drug: LY2127399', 'Drug: Placebo Q2W', 'Drug: Methotrexate']}], 'interventions': [{'name': 'LY2127399', 'type': 'DRUG', 'description': 'Administered Subcutaneously (SC)', 'armGroupLabels': ['120 milligrams (mg) LY2127399', '90 mg LY2127399', 'Placebo']}, {'name': 'Placebo Q2W', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo Q4W', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['120 milligrams (mg) LY2127399']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate is a background therapy.', 'armGroupLabels': ['120 milligrams (mg) LY2127399', '90 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': '35801', 'city': 'Huntsville', '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': 34.7304, 'lon': -86.58594}}, {'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': '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': '92027', 'city': 'Escondido', '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': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', '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': 36.74773, 'lon': -119.77237}}, {'zip': '92543', 'city': 'Hemet', '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': 33.74761, 'lon': -116.97307}}, {'zip': '92037', 'city': 'La Jolla', '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': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', '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': 32.76783, 'lon': -117.02308}}, {'zip': '95825', 'city': 'Sacramento', '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': 38.58157, 'lon': -121.4944}}, {'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': '91786', 'city': 'Upland', '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': 34.09751, 'lon': -117.64839}}, {'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': '80209', 'city': 'Denver', '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': 39.73915, 'lon': -104.9847}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', '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': 41.39482, 'lon': -73.45401}}, {'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': '33472', 'city': 'Boynton Beach', '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': 26.52535, 'lon': -80.06643}}, {'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': '33609', 'city': 'Tampa', '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': 27.94752, 'lon': -82.45843}}, {'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': '32960', 'city': 'Vero Beach', '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': 27.63864, 'lon': -80.39727}}, {'zip': '30342', 'city': 'Atlanta', '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 - 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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': 33.68906, 'lon': -78.88669}}, {'zip': '57201', 'city': 'Watertown', 'state': 'South Dakota', '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': 44.89941, 'lon': -97.11507}}, {'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': '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': 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': '78215', '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': '76708', 'city': 'Waco', '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': 31.54933, 'lon': -97.14667}}, {'zip': '53406', 'city': 'Racine', 'state': 'Wisconsin', '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': 42.72613, 'lon': -87.78285}}, {'zip': 'C1280AEB', 'city': 'Buenos Aires', 'country': 'Argentina', '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': -38.00042, 'lon': -57.5562}}, {'zip': 'B1878DVC', 'city': 'Quilmes', 'country': 'Argentina', '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': -34.72065, 'lon': -58.25454}}, {'zip': '5400', 'city': 'San Juan', 'country': 'Argentina', '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': -31.53726, 'lon': -68.52568}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', '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': -26.81601, 'lon': -65.21051}}, {'zip': '2560', 'city': 'Campbelltown', 'state': 'New South Wales', 'country': 'Australia', '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': -34.06667, 'lon': 150.81667}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', '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': -27.44453, 'lon': 153.01852}}, {'zip': '3145', 'city': 'Malvern East', 'country': 'Australia', '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': -37.87397, 'lon': 145.04253}}, {'zip': '13059-000', 'city': 'Campinas', 'country': 'Brazil', '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': -22.90556, 'lon': -47.06083}}, {'zip': '95070-560', 'city': 'Caxias do Sul', 'country': 'Brazil', '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': -29.16806, 'lon': -51.17944}}, {'zip': '80060-240', 'city': 'Curitiba', 'country': 'Brazil', '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': -25.42778, 'lon': -49.27306}}, {'zip': '60150-170', 'city': 'Fortaleza', 'country': 'Brazil', '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': -3.71722, 'lon': -38.54306}}, {'zip': '74110-120', 'city': 'Goiânia', 'country': 'Brazil', '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': -16.67861, 'lon': -49.25389}}, {'zip': '36010-570', 'city': 'Juiz de Fora', 'country': 'Brazil', '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': -21.76417, 'lon': -43.35028}}, {'zip': '20551-030', 'city': 'Rio de Janeiro', 'country': 'Brazil', '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': -22.90642, 'lon': -43.18223}}, {'zip': '09090780', 'city': 'São Paulo', 'country': 'Brazil', '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': -23.5475, 'lon': -46.63611}}, {'zip': '8000', 'city': 'Burgas', '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': 42.50651, 'lon': 27.46886}}, {'zip': '5800', 'city': 'Pleven', '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': 43.41791, 'lon': 24.61666}}, {'zip': '4003', 'city': 'Plovdiv', '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': 42.15387, 'lon': 24.75001}}, {'zip': '7002', 'city': 'Rousse', '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': 43.84872, 'lon': 25.9534}}, {'zip': '5400', 'city': 'Sevlievo', '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': 43.02295, 'lon': 25.10364}}, {'zip': '1784', 'city': 'Sofia', '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': 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': '31000', 'city': 'Osijek', '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': 45.55066, 'lon': 18.6942}}, {'zip': '51 000', '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': '6500', 'city': 'Baja', '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': 46.18299, 'lon': 18.95307}}, {'zip': '2660', 'city': 'Balassagyarmat', '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': 48.07296, 'lon': 19.29614}}, {'zip': '1095', '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': '4012', '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': '2500', 'city': 'Esztergom', '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': 47.7928, 'lon': 18.74148}}, {'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': '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': '500082', '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': '302019', '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': '226 014', 'city': 'Lucknow', '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': 26.83928, 'lon': 80.92313}}, {'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': '395003', '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': '284-0003', 'city': 'Chiba', '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': 35.6, 'lon': 140.11667}}, {'zip': '807-8555', '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': '060-8604', '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': '305-8576', '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': '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': '104-8560', 'city': 'Japan', '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': '891-0133', 'city': 'Kagoshima', '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': 31.56667, 'lon': 130.55}}, {'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': '880-0122', 'city': 'Miyazaki', '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': 31.91667, 'lon': 131.41667}}, {'zip': '380-8582', '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': '710-0016', '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': '770-8503', 'city': 'Tokushima', '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': 34.06667, 'lon': 134.56667}}, {'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': '933-0874', 'city': 'Toyama', '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': 36.7, 'lon': 137.21667}}, {'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': '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': '15586', 'city': 'Kota Bharu', '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': 6.12361, 'lon': 102.24333}}, {'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': '62250', 'city': 'Putrajaya', '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': 2.93527, 'lon': 101.69112}}, {'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': '52140', 'city': 'Barrio San Mateo', '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': 19.86126, 'lon': -98.7376}}, {'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': '14050', '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': '64460', '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': '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': '13-200', 'city': 'Działdowo', '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': 53.23958, 'lon': 20.17004}}, {'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 - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '20-607', 'city': 'Lublin', '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': 51.25058, 'lon': 22.57009}}, {'zip': '09-400', 'city': 'Płock', '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': 52.54682, 'lon': 19.70638}}, {'zip': '87-100', 'city': 'Torun', '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': 53.01375, 'lon': 18.59814}}, {'zip': '01-192', 'city': 'Warsaw', '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': 52.22977, 'lon': 21.01178}}, {'zip': '29-100', 'city': 'Włoszczowa', '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': 50.85256, 'lon': 19.96593}}, {'zip': '500365', 'city': 'Brasov', 'country': 'Romania', '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': 45.64861, 'lon': 25.60613}}, {'zip': '400130', 'city': 'Cluj-Napoca', 'country': 'Romania', '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': 46.76667, 'lon': 23.6}}, {'zip': '700656', 'city': 'Iași', 'country': 'Romania', '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': 47.16667, 'lon': 27.6}}, {'zip': '100337', 'city': 'Ploieşti', 'country': 'Romania', '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': 44.95, 'lon': 26.01667}}, {'zip': '656038', 'city': 'Barnaul', 'country': 'Russia', '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': 53.36199, 'lon': 83.72786}}, {'zip': '420029', 'city': "Kazan'", 'country': 'Russia', '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': 55.78874, 'lon': 49.12214}}, {'zip': '650066', 'city': 'Kemerovo', 'country': 'Russia', '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': 55.35417, 'lon': 86.10435}}, {'zip': '628012', 'city': 'Khanty-Mansiysk', 'country': 'Russia', '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': 61.00187, 'lon': 69.02728}}, {'zip': '125299', 'city': 'Moscow', 'country': 'Russia', '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': 55.75204, 'lon': 37.61781}}, {'zip': '630047', 'city': 'Novosibirsk', 'country': 'Russia', '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': 55.02259, 'lon': 82.93175}}, {'zip': '185019', 'city': 'Petrozavodsk', 'country': 'Russia', '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': 61.78491, 'lon': 34.34691}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', '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': 54.62696, 'lon': 39.70415}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', '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': 59.93863, 'lon': 30.31413}}, {'zip': '410002', 'city': 'Saratov', 'country': 'Russia', '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': 51.54048, 'lon': 45.9901}}, {'zip': '355017', 'city': 'Stavropol', 'country': 'Russia', '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': 45.03442, 'lon': 41.9642}}, {'zip': '394066', 'city': 'Voronezh', 'country': 'Russia', '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': 51.66833, 'lon': 39.19204}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', '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': 57.62987, 'lon': 39.87368}}, {'zip': '84231', 'city': 'Bratislava', 'country': 'Slovakia', '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': 48.14816, 'lon': 17.10674}}, {'zip': '929 01', 'city': 'Dunajská Streda', 'country': 'Slovakia', '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': 47.99268, 'lon': 17.61211}}, {'zip': '921 12', 'city': 'Piešťany', 'country': 'Slovakia', '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': 48.59479, 'lon': 17.82591}}, {'zip': '1500', 'city': 'Benoni', 'country': 'South Africa', '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': -26.18848, 'lon': 28.32078}}, {'zip': '9301', 'city': 'Bloemfontein', 'country': 'South Africa', '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': -29.12107, 'lon': 26.214}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', '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': -33.92584, 'lon': 18.42322}}, {'zip': '4001', 'city': 'Durban', 'country': 'South Africa', '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': -29.8579, 'lon': 31.0292}}, {'zip': '0380', 'city': 'Limpopo', 'country': 'South Africa', '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': '0084', 'city': 'Pretoria', 'country': 'South Africa', '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': -25.74486, 'lon': 28.18783}}, {'zip': '7130', 'city': 'Somerset West', 'country': 'South Africa', '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': -34.08401, 'lon': 18.82113}}, {'zip': '7600', 'city': 'Stellenbosch', 'country': 'South Africa', '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': -33.93462, 'lon': 18.86676}}, {'zip': '602-715', 'city': 'Busan', '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': 35.10168, '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': '301-721', 'city': 'Daejeon', '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': 36.34913, 'lon': 127.38493}}, {'zip': '400-711', 'city': 'Incheon', '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': 37.45646, 'lon': 126.70515}}, {'zip': '463-707', 'city': 'Seongnam-si', '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': 37.43861, 'lon': 127.13778}}, {'zip': '143-729', '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}}, {'zip': '442-721', 'city': 'Suwon', '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': 37.29111, 'lon': 127.00889}}, {'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 - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 6.93548, 'lon': 79.84868}}, {'city': 'Galle', '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 - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 6.0461, 'lon': 80.2103}}, {'city': 'Kalubowila', '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 - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 6.8651, 'lon': 79.8709}}, {'city': 'Nugegoda', '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 - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 6.8735, 'lon': 79.8899}}, {'zip': '613', 'city': 'Chiayi City', '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': 23.47917, 'lon': 120.44889}}, {'zip': '204', 'city': 'Keelung', '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': 25.13089, 'lon': 121.74094}}, {'zip': '33305', 'city': 'Kuei Shan Hsiang', '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.'}, {'zip': '833', 'city': 'Niao Sung Hsiang', '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.'}, {'zip': '404', 'city': 'Taichung', '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': 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 - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '61178', 'city': 'Kharkiv', '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': 49.98177, 'lon': 36.25475}}, {'zip': '03151', 'city': 'Kyiv', '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': 50.45466, 'lon': 30.5238}}, {'zip': '65026', 'city': 'Odesa', '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': 46.48572, 'lon': 30.74383}}, {'zip': '36038', 'city': 'Poltava', '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': 49.58925, 'lon': 34.55367}}, {'zip': '21018', 'city': 'Vinnytsia', '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': 49.2322, 'lon': 28.46871}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}