Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-12 @ 4:31 AM
Study NCT ID:
NCT00663702
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IIIB Switching From Intravenous to Subcutaneous Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.', 'otherNumAtRisk': 123, 'otherNumAffected': 101, 'seriousNumAtRisk': 123, 'seriousNumAffected': 43}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Brain neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gallbladder adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs leading to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AEIs: Infections', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'AEIs: Malignancy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AEIs: Automimmune disorders (prespecified)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AEIs: Injection reactions (prespecified) Local', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AEIs: Injection reactions (prespecified) Systemic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through Day 85', 'description': 'An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication'}, {'type': 'SECONDARY', 'title': 'Mean Trough Serum Concentration (Cmin) of Abatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Day 29 (n=116)', 'categories': [{'measurements': [{'value': '34.31', 'spread': '46', 'groupId': 'OG000'}]}]}, {'title': 'Day 57 (n=117)', 'categories': [{'measurements': [{'value': '34.25', 'spread': '48', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 (n=118)', 'categories': [{'measurements': [{'value': '33.78', 'spread': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 29, 85, 57, and 85', 'description': 'Cmin of abatacept was determined from serum samples.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related SAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'SAEs leading to discontinuation', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Hemoglobin, low (n=120)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, low (n=119)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, low (n=120)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, low (n=120)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, low (n=120)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, high (n=120)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils (absolute), high (n=122)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes (absolute), low (n=122)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) \\>3 decrease from preRx. Hematocrit (%)\\<0.75\\*preRx. Erythrocytes (\\*10\\^6 c/uL) \\<0.75\\*preRx. Platelet count (\\*10\\^9 c/L) \\<0.67\\*LLN or 1.5\\*ULN or, if preRx\\<LLN, use \\<0.5\\*preRx and \\<100,000 mm\\^3. Leukocytes (\\*10\\^3 c/uL) \\<0.75\\*LLN or \\>1.25\\*ULN or, if preRx\\<LLN, use \\<0.8\\*preRx or \\>ULN or, if preRx\\>ULN, use \\>1.2\\*preRx or \\<LLN. Eosinophils \\>0.750\\*10\\^3 c/uL. Lymphocytes \\<0.750\\*10\\^3 c/uL or \\>7.50\\*10\\^3 c/uL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Alkaline phosphatase, high (n=120)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase, high (n=120)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, high (n=120)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'G-glutamyl transferase, high (n=120)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, high (n=120)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, high (n=120)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) \\>2\\*ULN or if preRx\\>ULN, use 3\\*preRx. Alanine aminotransferase (U/L)\\>3\\*ULN or if preRx\\>ULN, use \\>4\\*preRx. G-glutamyl transferase (U/L)\\>2\\*ULN or if preRx\\>ULN, use \\>3\\*preRx. Blood urea nitrogen (mg/dL)\\>2\\*preRx. Creatinine (mg/dL)\\>1.5\\*preRx.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Sodium, serum, low (mEq/L) (n=120)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, serum, low (mEq/L) (n=120)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus, inorganic, low (mg/dL) (n=120)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: \\<0.95\\*LLN or \\>1.05\\*ULN or if preRx\\<LLN, \\<0.95\\*preRx or \\>ULN, or if preRx\\>ULN,\\>1.05\\*preRx or \\<LLN. Potassium,serum: \\<0.9\\*LLN or \\>1.1\\*ULN or if preRx\\<LLN, use \\<0.9\\*preRx or \\>ULN or if preRx\\>ULN, 1.1\\*preRx or \\<LLN. Phosphorus: 0.75\\*LLN or 1.25\\*ULN or, if preRx\\<LLN, \\<0.67\\*preRx or \\>ULN or, if preRx\\>ULN, \\<LLN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Glucose, serum, low (n=122)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, serum, high (n=122)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, serum, fasting, low (n=59)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, serum, fasting, high (n=59)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Protein, total, low (n=120)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Protein, total, high (n=120)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, low (n=120)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Anti-abatacept (n=85)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Anti-CTLA4-T9 (n=122)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through Day 85', 'description': 'Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through Day 85', 'description': 'Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers \\>10) included:\n\n* A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline\n* A negative baseline immunogenicity response and a positive immunogenicity response postbaseline\n* A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable'}, {'type': 'SECONDARY', 'title': 'Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb \\[BMS\\] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}, {'id': 'OG001', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Day 29 (n=50, 69)', 'categories': [{'measurements': [{'value': '3.60', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '2.95', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=49, 69)', 'categories': [{'measurements': [{'value': '3.36', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=49, 70)', 'categories': [{'measurements': [{'value': '3.44', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=48, 71)', 'categories': [{'measurements': [{'value': '3.45', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 253 (n=46, 71)', 'categories': [{'measurements': [{'value': '3.60', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=45, 70)', 'categories': [{'measurements': [{'value': '3.51', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=43, 69)', 'categories': [{'measurements': [{'value': '3.58', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=43, 68)', 'categories': [{'measurements': [{'value': '3.51', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=41, 67)', 'categories': [{'measurements': [{'value': '3.31', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=41, 67)', 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=39, 65)', 'categories': [{'measurements': [{'value': '3.38', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=38, 65)', 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=38, 65)', 'categories': [{'measurements': [{'value': '3.32', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 1093 (n=34, 65)', 'categories': [{'measurements': [{'value': '3.21', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '1.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 1093', 'description': "The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb \\[BMS\\] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}, {'id': 'OG001', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'LDAS Day 29 (n=50, 69)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '53.6'}, {'value': '68.1', 'groupId': 'OG001', 'lowerLimit': '57.1', 'upperLimit': '79.1'}]}]}, {'title': 'Remission Day 29 (n=50, 69)', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '35.8'}, {'value': '50.7', 'groupId': 'OG001', 'lowerLimit': '38.9', 'upperLimit': '62.5'}]}]}, {'title': 'LDAS Day 57 (n=49, 69)', 'categories': [{'measurements': [{'value': '44.9', 'groupId': 'OG000', 'lowerLimit': '31.0', 'upperLimit': '58.8'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '49.4', 'upperLimit': '72.4'}]}]}, {'title': 'Remission Day 57 (n=49, 69)', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '38.9'}, {'value': '47.8', 'groupId': 'OG001', 'lowerLimit': '36.0', 'upperLimit': '59.6'}]}]}, {'title': 'LDAS Day 85 (n=49, 70)', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '54.6'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '53.1', 'upperLimit': '75.5'}]}]}, {'title': 'Remission Day 85 (n=49, 70)', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '36.5'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '36.9', 'upperLimit': '60.3'}]}]}, {'title': 'LDAS Day 169 (n=48, 71)', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '53.4'}, {'value': '59.2', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '70.6'}]}]}, {'title': 'Remission Day 169 (n=48, 71)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '37.2'}, {'value': '49.3', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '60.9'}]}]}, {'title': 'LDAS Day 253 (n=46, 71)', 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '53.2'}, {'value': '66.2', 'groupId': 'OG001', 'lowerLimit': '55.2', 'upperLimit': '77.2'}]}]}, {'title': 'Remission Day 253 (n=46, 71)', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '43.7'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '30.8', 'upperLimit': '53.7'}]}]}, {'title': 'LDAS Day 365 (n=45, 70)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '54.3'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '45.5', 'upperLimit': '68.7'}]}]}, {'title': 'Remission Day 365 (n=45, 70)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '47.1'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '31.3', 'upperLimit': '54.5'}]}]}, {'title': 'LDAS Day 449 (n=43, 69)', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '56.6'}, {'value': '53.6', 'groupId': 'OG001', 'lowerLimit': '41.9', 'upperLimit': '65.4'}]}]}, {'title': 'Remission Day 449 (n=43, 69)', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '44.0'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '31.8', 'upperLimit': '55.2'}]}]}, {'title': 'LDAS Day 533 (n=43, 68)', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '51.7'}, {'value': '60.3', 'groupId': 'OG001', 'lowerLimit': '48.7', 'upperLimit': '71.9'}]}]}, {'title': 'Remission Day 533 (n=43, 68)', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '35.9'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '36.7', 'upperLimit': '60.4'}]}]}, {'title': 'LDAS Day 617 (n=41, 67)', 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '61.6'}, {'value': '53.7', 'groupId': 'OG001', 'lowerLimit': '41.8', 'upperLimit': '65.7'}]}]}, {'title': 'Remission Day 617 (n=41, 67)', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '43.2'}, {'value': '43.3', 'groupId': 'OG001', 'lowerLimit': '31.4', 'upperLimit': '55.1'}]}]}, {'title': 'LDAS Day 729 (n=41, 67)', 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '56.5'}, {'value': '59.7', 'groupId': 'OG001', 'lowerLimit': '48.0', 'upperLimit': '71.4'}]}]}, {'title': 'Remission Day 729 (n=41, 67)', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '43.2'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '45.7'}]}]}, {'title': 'LDAS Day 813 (n=39, 65)', 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '59.2'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '58.0', 'upperLimit': '80.5'}]}]}, {'title': 'Remission Day 813 (n=39, 65)', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '39.3'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '34.0', 'upperLimit': '58.3'}]}]}, {'title': 'LDAS Day 897 (n=38, 65)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '65.9'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '48.1', 'upperLimit': '71.9'}]}]}, {'title': 'Remission Day 897 (n=38, 65)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '49.3'}, {'value': '43.1', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': '55.1'}]}]}, {'title': 'DLAS Day 981 (n=38, 65)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '65.9'}, {'value': '64.6', 'groupId': 'OG001', 'lowerLimit': '53.0', 'upperLimit': '76.2'}]}]}, {'title': 'Remission Day 981 (n=38, 65)', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '57.8'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '34.0', 'upperLimit': '58.3'}]}]}, {'title': 'LDAS Day 1093 (n=34, 65)', 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '36.2', 'upperLimit': '69.7'}, {'value': '58.5', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '70.4'}]}]}, {'title': 'Remission Day 1093 (n=34, 65)', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '57.7'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '38.6', 'upperLimit': '62.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through Day 1093', 'description': "LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP \\<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication'}, {'type': 'SECONDARY', 'title': 'Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb \\[BMS\\] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}, {'id': 'OG001', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Day 29 (n=51, 69)', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (n=50, 71)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (n=49, 71)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (n=49, 71)', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Day 253 (n=48, 71)', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 365 (n=46, 70)', 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 449 (n=43, 69)', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 533 (n=43, 68)', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 617 (n=42, 67)', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 729 (n=42, 67)', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 813 (n=40, 66)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 897 (n=39, 65)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 981 (n=39, 65)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 1093 (n=34, 65)', 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) to Day 1093', 'description': "The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication'}, {'type': 'PRIMARY', 'title': 'Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Protein, urine, high (n=122)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, urine, high (n=122)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Blood, urine, high (n=122)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Leukocyte esterase, urine, high (n=95)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'White blood cells, urine, high (n=103)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cells, urine, high (n=91)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use \\>=2 or, if value \\>= 4, or if preRx=0 or 0.5, use \\>=2 or, if preRx= 1, use \\>=3 or, if preRx=2 or 3, use \\>=4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Infections', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Malignancies', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Prespecified autoimmune disorders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Prespecified systemic injection reactions', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period', 'description': 'AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Mean Sitting Systolic and Diastolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Sitting Systolic BP Day 1', 'categories': [{'measurements': [{'value': '121.6', 'spread': '16.15', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 29 (n=120)', 'categories': [{'measurements': [{'value': '123.6', 'spread': '16.08', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 57 (n=120)', 'categories': [{'measurements': [{'value': '123.9', 'spread': '16.95', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 85 (n=120)', 'categories': [{'measurements': [{'value': '124.3', 'spread': '16.62', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 169 (n=116)', 'categories': [{'measurements': [{'value': '124.0', 'spread': '15.09', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 253 (n=114)', 'categories': [{'measurements': [{'value': '122.3', 'spread': '14.58', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 365 (n=114)', 'categories': [{'measurements': [{'value': '124.1', 'spread': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 449 (n=111)', 'categories': [{'measurements': [{'value': '123.9', 'spread': '15.80', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 533 (n=108)', 'categories': [{'measurements': [{'value': '123.5', 'spread': '15.08', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 617 (n=109)', 'categories': [{'measurements': [{'value': '124.4', 'spread': '16.03', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 729 (n=108)', 'categories': [{'measurements': [{'value': '125.2', 'spread': '16.09', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 813 (n=105)', 'categories': [{'measurements': [{'value': '125.6', 'spread': '16.04', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 897 (n=102)', 'categories': [{'measurements': [{'value': '122.8', 'spread': '13.15', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 981 (n=101)', 'categories': [{'measurements': [{'value': '123.5', 'spread': '15.44', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1093 (n=98)', 'categories': [{'measurements': [{'value': '122.9', 'spread': '13.46', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1177 (n=84)', 'categories': [{'measurements': [{'value': '124.4', 'spread': '13.66', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1261 (n=73)', 'categories': [{'measurements': [{'value': '123.0', 'spread': '15.29', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1345 (n=64)', 'categories': [{'measurements': [{'value': '120.6', 'spread': '12.27', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1457 (n=64)', 'categories': [{'measurements': [{'value': '124.5', 'spread': '13.17', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1541 (n=64)', 'categories': [{'measurements': [{'value': '121.0', 'spread': '13.75', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1625 (n=64)', 'categories': [{'measurements': [{'value': '123.4', 'spread': '14.71', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1709 (n=48)', 'categories': [{'measurements': [{'value': '122.7', 'spread': '15.55', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Systolic BP Day 1821 (n=3)', 'categories': [{'measurements': [{'value': '123.7', 'spread': '15.18', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1 (n=123)', 'categories': [{'measurements': [{'value': '73.9', 'spread': '8.83', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 29 (n=120)', 'categories': [{'measurements': [{'value': '75.6', 'spread': '9.28', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 57 (n=120)', 'categories': [{'measurements': [{'value': '74.3', 'spread': '8.82', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 85 (n=120)', 'categories': [{'measurements': [{'value': '74.9', 'spread': '10.37', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 169 (n=116)', 'categories': [{'measurements': [{'value': '74.3', 'spread': '9.19', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 253 (n=114)', 'categories': [{'measurements': [{'value': '73.9', 'spread': '9.96', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 365 (n=114)', 'categories': [{'measurements': [{'value': '74.0', 'spread': '9.98', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 449 (n=111)', 'categories': [{'measurements': [{'value': '74.4', 'spread': '9.53', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 533 (n=108)', 'categories': [{'measurements': [{'value': '74.8', 'spread': '10.08', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 617 (n=109)', 'categories': [{'measurements': [{'value': '74.9', 'spread': '9.72', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 79 (n=108)', 'categories': [{'measurements': [{'value': '75.5', 'spread': '9.83', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 813 (n=105)', 'categories': [{'measurements': [{'value': '75.8', 'spread': '10.20', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 897 (n=102)', 'categories': [{'measurements': [{'value': '75.0', 'spread': '10.23', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 981 (n=101)', 'categories': [{'measurements': [{'value': '75.2', 'spread': '9.35', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1093 (n=98)', 'categories': [{'measurements': [{'value': '76.2', 'spread': '10.78', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day1177 (n=84)', 'categories': [{'measurements': [{'value': '77.6', 'spread': '9.04', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1261 (n=73)', 'categories': [{'measurements': [{'value': '76.3', 'spread': '9.94', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1345 (n=64)', 'categories': [{'measurements': [{'value': '75.4', 'spread': '8.21', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1457 (n=64)', 'categories': [{'measurements': [{'value': '76.8', 'spread': '7.14', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1541 (n=64)', 'categories': [{'measurements': [{'value': '75.6', 'spread': '9.53', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1625 (n=64)', 'categories': [{'measurements': [{'value': '75.6', 'spread': '9.36', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1709 (n=48)', 'categories': [{'measurements': [{'value': '75.2', 'spread': '9.74', 'groupId': 'OG000'}]}]}, {'title': 'Sitting Diastolic BP Day 1821 (n=3)', 'categories': [{'measurements': [{'value': '69.3', 'spread': '8.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821', 'description': 'BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}, {'type': 'PRIMARY', 'title': 'Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '74.2', 'spread': '9.56', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (n=120)', 'categories': [{'measurements': [{'value': '74.9', 'spread': '8.35', 'groupId': 'OG000'}]}]}, {'title': 'Day 57 (n=120)', 'categories': [{'measurements': [{'value': '74.6', 'spread': '8.63', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 (n=120)', 'categories': [{'measurements': [{'value': '74.5', 'spread': '8.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 169 (n=119)', 'categories': [{'measurements': [{'value': '73.6', 'spread': '9.05', 'groupId': 'OG000'}]}]}, {'title': 'Day 253 (n=115)', 'categories': [{'measurements': [{'value': '73.9', 'spread': '9.74', 'groupId': 'OG000'}]}]}, {'title': 'Day 365 (n=114)', 'categories': [{'measurements': [{'value': '73.8', 'spread': '9.37', 'groupId': 'OG000'}]}]}, {'title': 'Day 449 (n=111)', 'categories': [{'measurements': [{'value': '73.5', 'spread': '9.12', 'groupId': 'OG000'}]}]}, {'title': 'Day 533 (n=109)', 'categories': [{'measurements': [{'value': '72.7', 'spread': '8.41', 'groupId': 'OG000'}]}]}, {'title': 'Day 617 (n=109)', 'categories': [{'measurements': [{'value': '73.6', 'spread': '9.83', 'groupId': 'OG000'}]}]}, {'title': 'Day 729 (n=108)', 'categories': [{'measurements': [{'value': '74.2', 'spread': '9.71', 'groupId': 'OG000'}]}]}, {'title': 'Day 813 (n=105)', 'categories': [{'measurements': [{'value': '72.8', 'spread': '7.76', 'groupId': 'OG000'}]}]}, {'title': 'Day 897 (n=102)', 'categories': [{'measurements': [{'value': '72.4', 'spread': '10.05', 'groupId': 'OG000'}]}]}, {'title': 'Day 981 (n=101)', 'categories': [{'measurements': [{'value': '73.0', 'spread': '8.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 1093 (n=98)', 'categories': [{'measurements': [{'value': '71.9', 'spread': '9.07', 'groupId': 'OG000'}]}]}, {'title': 'Day 1177 (n=84)', 'categories': [{'measurements': [{'value': '72.6', 'spread': '8.33', 'groupId': 'OG000'}]}]}, {'title': 'Day 1261 (n=73)', 'categories': [{'measurements': [{'value': '72.3', 'spread': '9.41', 'groupId': 'OG000'}]}]}, {'title': 'Day 1345 (n=64)', 'categories': [{'measurements': [{'value': '72.6', 'spread': '8.02', 'groupId': 'OG000'}]}]}, {'title': 'Day 1457 (n=64)', 'categories': [{'measurements': [{'value': '72.1', 'spread': '7.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 1541 (n=64)', 'categories': [{'measurements': [{'value': '72.7', 'spread': '8.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 1625 (n=64)', 'categories': [{'measurements': [{'value': '72.5', 'spread': '8.73', 'groupId': 'OG000'}]}]}, {'title': 'Day 1709 (n=48)', 'categories': [{'measurements': [{'value': '74.0', 'spread': '9.78', 'groupId': 'OG000'}]}]}, {'title': 'Day 1821 (n=3)', 'categories': [{'measurements': [{'value': '74.0', 'spread': '6.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821', 'description': 'Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}, {'type': 'PRIMARY', 'title': 'Mean Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept, 125 mg', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.49', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (n=120)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Day 57 (n=120)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 (n=120)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Day 169 (n=119)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Day 253 (n=115)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 365 (n=114)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Day 449 (n=111)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Day 533 (n=109)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 617 (n=109)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Day 729 (n=108)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.33', 'groupId': 'OG000'}]}]}, {'title': 'Day 813 (n=105)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Day 897 (n=102)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Day 981 (n=101)', 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Day 1093 (n=98)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Day 1177 (n=84)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Day 1261 (n=73)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Day 1345 (n=64)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.33', 'groupId': 'OG000'}]}]}, {'title': 'Day 1457 (n=64)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Day 1541 (n=64)', 'categories': [{'measurements': [{'value': '36.2', 'spread': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Day 1625 (n=64)', 'categories': [{'measurements': [{'value': '36.2', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Day 1709 (n=48)', 'categories': [{'measurements': [{'value': '36.2', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Day 1821 (n=3)', 'categories': [{'measurements': [{'value': '36.7', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821', 'description': 'Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.', 'unitOfMeasure': 'Degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication. n=patients evaluable'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb \\[BMS\\] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}, {'id': 'FG001', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 3 locations and 32 sites worldwide: United States (20 sites), Canada (6 sites), and Mexico (6 sites).', 'preAssignmentDetails': 'A total of 126 participants were enrolled, and 3 discontinued prior to study start due to failure to continue to meet study eligibility criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}, {'id': 'BG001', 'title': 'Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)', 'description': 'Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Partcipants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'South America', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Baseline High Sensitivity C-Reactive Protein Level', 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '0.65', 'groupId': 'BG000'}, {'value': '0.92', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '0.93', 'spread': '0.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Baseline 28 Joint Disease Activity Score (DAS 28)', 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '1.20', 'groupId': 'BG000'}, {'value': '3.28', 'spread': '1.29', 'groupId': 'BG001'}, {'value': '3.39', 'spread': '1.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The DAS 28 is a 28-item joint disease activity score used to quantify disease expression and progression in rheumatoid arthritis. Severity is indicated with increasing item score on the scale with 0=no joints affected and 28=all joints affected.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Number of Tender Joints at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '8.8', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Number of Swollen Joints at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Participant Weight at Baseline', 'classes': [{'title': 'Less than 60 kilograms', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': '60-100 kilograms', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'Greater than 100 kilograms', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-17', 'studyFirstSubmitDate': '2008-04-18', 'resultsFirstSubmitDate': '2012-01-19', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-22', 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85', 'timeFrame': 'Day 1 (Baseline) through Day 85', 'description': 'An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.'}, {'measure': 'Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.'}, {'measure': 'Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) \\>3 decrease from preRx. Hematocrit (%)\\<0.75\\*preRx. Erythrocytes (\\*10\\^6 c/uL) \\<0.75\\*preRx. Platelet count (\\*10\\^9 c/L) \\<0.67\\*LLN or 1.5\\*ULN or, if preRx\\<LLN, use \\<0.5\\*preRx and \\<100,000 mm\\^3. Leukocytes (\\*10\\^3 c/uL) \\<0.75\\*LLN or \\>1.25\\*ULN or, if preRx\\<LLN, use \\<0.8\\*preRx or \\>ULN or, if preRx\\>ULN, use \\>1.2\\*preRx or \\<LLN. Eosinophils \\>0.750\\*10\\^3 c/uL. Lymphocytes \\<0.750\\*10\\^3 c/uL or \\>7.50\\*10\\^3 c/uL.'}, {'measure': 'Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) \\>2\\*ULN or if preRx\\>ULN, use 3\\*preRx. Alanine aminotransferase (U/L)\\>3\\*ULN or if preRx\\>ULN, use \\>4\\*preRx. G-glutamyl transferase (U/L)\\>2\\*ULN or if preRx\\>ULN, use \\>3\\*preRx. Blood urea nitrogen (mg/dL)\\>2\\*preRx. Creatinine (mg/dL)\\>1.5\\*preRx.'}, {'measure': 'Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: \\<0.95\\*LLN or \\>1.05\\*ULN or if preRx\\<LLN, \\<0.95\\*preRx or \\>ULN, or if preRx\\>ULN,\\>1.05\\*preRx or \\<LLN. Potassium,serum: \\<0.9\\*LLN or \\>1.1\\*ULN or if preRx\\<LLN, use \\<0.9\\*preRx or \\>ULN or if preRx\\>ULN, 1.1\\*preRx or \\<LLN. Phosphorus: 0.75\\*LLN or 1.25\\*ULN or, if preRx\\<LLN, \\<0.67\\*preRx or \\>ULN or, if preRx\\>ULN, \\<LLN.'}, {'measure': 'Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality', 'timeFrame': 'Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period', 'description': 'LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .'}, {'measure': 'Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality', 'timeFrame': 'Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period', 'description': 'preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use \\>=2 or, if value \\>= 4, or if preRx=0 or 0.5, use \\>=2 or, if preRx= 1, use \\>=3 or, if preRx=2 or 3, use \\>=4.'}, {'measure': 'Number of Participants With Adverse Events of Special Interest', 'timeFrame': 'Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period', 'description': 'AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).'}, {'measure': 'Mean Sitting Systolic and Diastolic Blood Pressure (BP)', 'timeFrame': 'Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821', 'description': 'BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.'}, {'measure': 'Mean Heart Rate', 'timeFrame': 'Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821', 'description': 'Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.'}, {'measure': 'Mean Temperature', 'timeFrame': 'Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821', 'description': 'Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.'}], 'secondaryOutcomes': [{'measure': 'Mean Trough Serum Concentration (Cmin) of Abatacept', 'timeFrame': 'Days 29, 85, 57, and 85', 'description': 'Cmin of abatacept was determined from serum samples.'}, {'measure': 'Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85', 'timeFrame': 'Day 1 (Baseline) through Day 85', 'description': 'Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.'}, {'measure': 'Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85', 'timeFrame': 'Day 1 (Baseline) through Day 85', 'description': 'Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers \\>10) included:\n\n* A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline\n* A negative baseline immunogenicity response and a positive immunogenicity response postbaseline\n* A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value'}, {'measure': 'Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time', 'timeFrame': 'Day 1 (Baseline) through Day 1093', 'description': "The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)"}, {'measure': 'Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:', 'timeFrame': 'Day 1 (Baseline) through Day 1093', 'description': "LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP \\<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)"}, {'measure': 'Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time', 'timeFrame': 'Day 1 (Baseline) to Day 1093', 'description': "The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '27229685', 'type': 'DERIVED', 'citation': 'Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether switching to subcutaneous administration of abatacept will be safe in participants with rheumatoid arthritis who previously received long-term therapy with intravenous abatacept'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recruitment from 2 Bristol-Myers Squibb (BMS) studies (BMS IM101-029 \\[NCT00048581\\] and BMS IM101-102 \\[NCT00048568\\]).\n* Completion of final quarterly dosing visit in NCT00048581 or NCT00048568 as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.\n* Agreement to participate in BMS IM101-185 (NCT00663702) on final quarterly dosing visit in NCT00048581 or NCT00048568 study as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.\n* At the time of completion of the NCT00048581 or NCT00048568 protocol, participant did not meet any criteria requiring their discontinuation.\n* Drug stabilization requirements: Participants who received concomitant medications (disease-modifying antirheumatic drugs, corticosteroids, and nonsteroidal anti-inflammatory drugs) at the time of their last quarterly dosing visit for NCT00048581 or NCT00048568 were required to maintain stable dose levels from the time they signed consent until the end of the first 3 months (Day 85) of the current study.\n* Willingness to self-inject study medication (abatacept) or allow a caregiver to inject study medication.\n* Willingness to adhere to study visit schedule and comply with other protocol requirements.\n* Male or female (not nursing or pregnant)genders, at least 18 years of age. Women of childbearing potential (WOCBP) must have been practicing adequate contraceptive measures during the study and for up to 10 weeks after the last infusion of study medication in such a manner that the risk of pregnancy was minimized. WOCBP must have had a negative serum or urine pregnancy test result (minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 48 hours prior to the start of study medication.\n\nExclusion Criteria:\n\n* The following treatment or therapies should not be started on or after the final quarterly dosing visit from the NCT00048581 or NCT00048568 study: Any biologic; immunoabsorption columns (such as Prosorba columns); mycophenolate mofetil; cyclosporin A or other calcineurin inhibitors; D-penicillamine; any live vaccines within 3 months of Day 1 or scheduled to receive a live vaccine during the course of the study\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, or a concomitant medical condition that, in the opinion of the Investigator, might have placed the participation at unacceptable risk for study participation\n* Any clinical laboratory test result that was considered to be abnormal or not within acceptable limits on the final quarterly dosing visit of NCT00048581 or NCT00048568. Screening laboratory test results for NCT00663702 were based on the Day 1821 visit of NCT00048581 or NCT00048568 for participants enrolled at sites in the US or Canada and on the Day 1989 visit of NCT00048568 for participants enrolled at sites in Mexico.\n* Imprisonment or involuntarily incarceration for treatment of either a psychiatric or physical (eg, infectious disease) illness\n* Impairment, incapacitation, inability to complete study-related assessments, or illiteracy.'}, 'identificationModule': {'nctId': 'NCT00663702', 'briefTitle': 'Phase IIIB Switching From Intravenous to Subcutaneous Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3B Multi-center Open-Label Study to Evaluate the Safety of Abatacept in Subjects Who Switch From Intravenous to Subcutaneous Abatacept Therapy', 'orgStudyIdInfo': {'id': 'IM101-185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Abatacept']}], 'interventions': [{'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia', 'BMS-188667'], 'description': 'Subcutaneous injection, 125 mg/mL, once weekly, 48 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates Of N. Al, P.C.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Allergy & Rheumatology Medical Clinic, Inc.', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Valerius Medical Group &Research Ctr. Of Greater Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Advances', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Inland Rheumatology Clinical Trials Inc.', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis & Rheumatic Disease Specialties', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Diagnostic Rheumatology And Research,Pc', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Graves Gilbert Clinic', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Physician Research Collaboration, Llc', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Innovative Health Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'The Center For Rheumatology, Llp', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Arthritis Clinic & Carolina Bone & Joint', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unifour Medical Research', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Rheumatic Disease Study Group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97035', 'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Rheumatology Clinic', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'zip': '19090', 'city': 'Willow Grove', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rheumatic Disease Associates, Ltd.', 'geoPoint': {'lat': 40.144, 'lon': -75.11573}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Walter F. Chase, Md', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Arthritis Centers Of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'T6G 2S2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'A1A 5E8', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'N2M 5N6', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 3M7', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '22320', 'city': 'Tijuana', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}, {'zip': '44690', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '06726', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64020', 'city': 'Nuevo León', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.65746, 'lon': -100.15538}}, {'zip': '78240', 'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}