Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00634933
Status:
TERMINATED
Last Update Posted:
2013-03-11
First Post:
2008-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540931', 'term': 'TRU-015 protein'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As the results of the primary analysis did not meet the predefined efficacy criteria, the development of TRU-015 was discontinued.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Part A)', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.', 'otherNumAtRisk': 74, 'otherNumAffected': 25, 'seriousNumAtRisk': 74, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'TRU-015 Single Dose (Part A)', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.', 'otherNumAtRisk': 75, 'otherNumAffected': 27, 'seriousNumAtRisk': 75, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'TRU-015 Induction Dose (Part A)', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.', 'otherNumAtRisk': 73, 'otherNumAffected': 25, 'seriousNumAtRisk': 73, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'TRU-015 Single Dose (Part B)', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.', 'otherNumAtRisk': 56, 'otherNumAffected': 22, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'TRU-015 Induction Dose (Part B)', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.', 'otherNumAtRisk': 55, 'otherNumAffected': 12, 'seriousNumAtRisk': 55, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Placebo/TRU-015 Single Dose (Part B)', 'description': 'TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.', 'otherNumAtRisk': 31, 'otherNumAffected': 18, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo/TRU-015 Induction Dose (Part B)', 'description': 'TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.', 'otherNumAtRisk': 32, 'otherNumAffected': 14, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}, {'value': '27.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.120', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'ACR50 response: greater than or equal to (\\>=) 50 percent (%) improvement in tender joint count; \\>=50% improvement in swollen joint count; and \\>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ-DI\\]); and C-Reactive Protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population included all randomized participants who received any portion of test article. Last observation carried forward (LOCF) method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '26.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '34.7', 'groupId': 'OG001'}, {'value': '34.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}, {'value': '42.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '52.0', 'groupId': 'OG001'}, {'value': '49.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '64.0', 'groupId': 'OG001'}, {'value': '61.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}, {'value': '64.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '61.3', 'groupId': 'OG001'}, {'value': '67.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.570', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.200', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.616', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.671', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.174', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'ACR20 response: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}, {'value': '13.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '30.7', 'groupId': 'OG001'}, {'value': '31.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}, {'value': '28.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.794', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.966', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.770', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.456', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.880', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.814', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.082', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52', 'description': 'ACR50 response: \\>=50% improvement in tender joint count; \\>=50% improvement in swollen joint count; and \\>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 20 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '9.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.338', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.983', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.296', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.573', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.563', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.768', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.977', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.249', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.268', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.079', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'ACR70 response: \\>=70% improvement in tender joint count; \\>=70% improvement in swollen joint count; and \\>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Number of Tender Joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.0', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '7.0', 'groupId': 'OG001'}, {'value': '17.7', 'spread': '6.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '13.6', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.9', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '11.7', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '10.1', 'spread': '7.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '11.0', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '9.4', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '7.0', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '7.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '9.0', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '9.4', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '7.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.', 'unitOfMeasure': 'tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Number of Swollen Joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '13.9', 'spread': '5.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '9.5', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '6.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '7.8', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '6.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '7.0', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '7.6', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '6.1', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '4.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '6.0', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '6.2', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Duration of Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes \\[24 hours\\*60 minutes\\] was recorded).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale for Pain (VAS-pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '65.4', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '62.5', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '61.6', 'spread': '23.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '53.0', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '47.7', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '49.6', 'spread': '24.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '53.6', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '49.0', 'spread': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '56.4', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '24.0', 'groupId': 'OG001'}, {'value': '47.0', 'spread': '24.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '54.3', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '24.1', 'groupId': 'OG001'}, {'value': '44.8', 'spread': '25.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '51.1', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '24.4', 'groupId': 'OG001'}, {'value': '40.8', 'spread': '25.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '51.1', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '24.2', 'groupId': 'OG001'}, {'value': '39.1', 'spread': '25.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '49.2', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '43.9', 'spread': '28.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': '100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Physician Global Assessment (PGA) of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment (PtGA) of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '6.6', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'General Health Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': '100 mm line (VAS) marked by participant. Participants were asked, "How do you feel concerning your arthritis?" Total possible score range, 0 mm = very well to 100 mm = extremely bad.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on 28-joints Count (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': "DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and participant's general health visual analog scale (scores ranging 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 less than or equal to (=\\<) 3.2 = low disease activity, DAS28 greater than (\\>) 3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}, {'type': 'SECONDARY', 'title': '36-Item Short-Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life (EQ-5D)- Health State Profile Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': "FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).", 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.'}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'OG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}], 'classes': [{'title': 'Week 2: good response', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 2: moderate response', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}, {'value': '38.7', 'groupId': 'OG001'}, {'value': '39.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 2: no response', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}, {'value': '54.7', 'groupId': 'OG001'}, {'value': '57.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 4: good response', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4: moderate response', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '41.3', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4: no response', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}, {'value': '46.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: good response', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '12.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: moderate response', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}, {'value': '53.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 8: no response', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}, {'value': '41.3', 'groupId': 'OG001'}, {'value': '34.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: good response', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: moderate response', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}, {'value': '52.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: no response', 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}, {'value': '25.3', 'groupId': 'OG001'}, {'value': '31.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: good response', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '34.7', 'groupId': 'OG001'}, {'value': '20.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: moderate response', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '41.3', 'groupId': 'OG001'}, {'value': '56.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16: no response', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '23.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 20: good response', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}, {'value': '26.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 20: moderate response', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '52.0', 'groupId': 'OG001'}, {'value': '54.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 20: no response', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 24: good response', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '30.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24: moderate response', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '50.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 24: no response', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.106', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.322', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.250', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.255', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 =\\< 3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to =\\<5.1 or change from baseline \\>0.6 to =\\<1.2 with DAS28 =\\<5.1; non-responders: change from baseline =\\< 0.6 or change from baseline \\>0.6 and =\\<1.2 with DAS28 \\>5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 milligram \\[mg\\]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.'}, {'id': 'FG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'FG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'FG003', 'title': 'Placebo/TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'FG004', 'title': 'Placebo/TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.'}], 'periods': [{'title': 'Part A: Baseline to Week 24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Failed to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Investigator Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Between Part A and Part B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part B: Week 24 to Week 52', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Discontinuation of Study by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'BG001', 'title': 'TRU-015 Single Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'BG002', 'title': 'TRU-015 Induction Dose', 'description': 'TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.62', 'spread': '11.07', 'groupId': 'BG000'}, {'value': '52.99', 'spread': '11.33', 'groupId': 'BG001'}, {'value': '52.55', 'spread': '13.00', 'groupId': 'BG002'}, {'value': '52.05', 'spread': '11.81', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'whyStopped': 'The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'dispFirstSubmitDate': '2012-07-17', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2008-03-05', 'dispFirstSubmitQcDate': '2012-07-17', 'resultsFirstSubmitDate': '2012-12-27', 'studyFirstSubmitQcDate': '2008-03-12', 'dispFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-06', 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24', 'timeFrame': 'Week 24', 'description': 'ACR50 response: greater than or equal to (\\>=) 50 percent (%) improvement in tender joint count; \\>=50% improvement in swollen joint count; and \\>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ-DI\\]); and C-Reactive Protein (CRP).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'ACR20 response: \\>= 20% improvement in tender joint count; \\>= 20% improvement in swollen joint count; and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.'}, {'measure': 'Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52', 'description': 'ACR50 response: \\>=50% improvement in tender joint count; \\>=50% improvement in swollen joint count; and \\>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.'}, {'measure': 'Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'ACR70 response: \\>=70% improvement in tender joint count; \\>=70% improvement in swollen joint count; and \\>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.'}, {'measure': 'Number of Tender Joints', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.'}, {'measure': 'Number of Swollen Joints', 'timeFrame': 'Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.'}, {'measure': 'Duration of Morning Stiffness', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes \\[24 hours\\*60 minutes\\] was recorded).'}, {'measure': 'Visual Analogue Scale for Pain (VAS-pain)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': '100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.'}, {'measure': 'Physician Global Assessment (PGA) of Disease Activity', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.'}, {'measure': 'Patient Global Assessment (PtGA) of Disease Activity', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.'}, {'measure': 'General Health Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': '100 mm line (VAS) marked by participant. Participants were asked, "How do you feel concerning your arthritis?" Total possible score range, 0 mm = very well to 100 mm = extremely bad.'}, {'measure': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.'}, {'measure': 'Disease Activity Score Based on 28-joints Count (DAS28)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': "DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and participant's general health visual analog scale (scores ranging 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 less than or equal to (=\\<) 3.2 = low disease activity, DAS28 greater than (\\>) 3.2 to 5.1 = moderate to high disease activity."}, {'measure': '36-Item Short-Form Health Survey (SF-36)', 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).'}, {'measure': 'Euro Quality of Life (EQ-5D)- Health State Profile Utility Score', 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state.'}, {'measure': 'Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.'}, {'measure': 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score', 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': "FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score)."}, {'measure': 'Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score', 'timeFrame': 'Baseline, Week 12, 24, 36, 52', 'description': 'WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.'}, {'measure': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28', 'timeFrame': 'Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 =\\< 3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to =\\<5.1 or change from baseline \\>0.6 to =\\<1.2 with DAS28 =\\<5.1; non-responders: change from baseline =\\< 0.6 or change from baseline \\>0.6 and =\\<1.2 with DAS28 \\>5.1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['active', 'rheumatoid', 'arthritis', 'anti CD20'], 'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3206K1-2203&StudyName=Study%20Evaluating%202%20Dosing%20Regimens%20Of%20TRU-015%20In%20Rheumatoid%20Arthritis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.\n\nExclusion Criteria:\n\n* Any prior use of rituximab or other B cell depleting agents.\n* Any significant health problem other than rheumatoid arthritis\n* Clinically significant laboratory abnormalities'}, 'identificationModule': {'nctId': 'NCT00634933', 'briefTitle': 'Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis', 'nctIdAliases': ['NCT01616706'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate', 'orgStudyIdInfo': {'id': '3206K1-2203'}, 'secondaryIdInfos': [{'id': 'B2051001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Consists of Arms 1a and 1b', 'interventionNames': ['Drug: TRU-015', 'Drug: Methylprednisolone', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Consists of Arms 2a and 2b', 'interventionNames': ['Drug: TRU-015', 'Drug: Methylprednisolone', 'Drug: Prednisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3', 'description': 'Consists of Arms 3a and 3b.', 'interventionNames': ['Drug: TRU-015', 'Drug: Methylprednisolone', 'Drug: Prednisone']}], 'interventions': [{'name': 'TRU-015', 'type': 'DRUG', 'description': 'IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).', 'armGroupLabels': ['Arm 1']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).', 'armGroupLabels': ['Arm 1']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)', 'armGroupLabels': ['Arm 1']}, {'name': 'TRU-015', 'type': 'DRUG', 'description': 'IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).', 'armGroupLabels': ['Arm 2']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).', 'armGroupLabels': ['Arm 2']}, {'name': 'Prednisone', 'type': 'DRUG', 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