Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT02915159
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2016-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, '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', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose to 169 days past open label period', 'eventGroups': [{'id': 'EG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 47, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 40, 'seriousNumAtRisk': 95, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Abatacept - Open Label Treatment Period', 'description': 'Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 178, 'otherNumAffected': 61, 'seriousNumAtRisk': 178, 'deathsNumAffected': 1, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hepatic cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Anaphylactoid reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haemophagocytic lymphohistiocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hip deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '-1.9'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '-2.4'}]}]}], 'analyses': [{'pValue': '0.4421', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'longitudinal repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 169', 'description': "The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.\n\nThe EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.\n\nDomain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)\n\n(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)\n\nOverall score, which can range from 0 to 123, a higher score indicates more disease activity", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat (ITT) analysis population: all randomized participants who receive at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.26', 'groupId': 'OG000', 'lowerLimit': '-1.88', 'upperLimit': '-0.64'}, {'value': '-1.52', 'groupId': 'OG001', 'lowerLimit': '-2.12', 'upperLimit': '-0.93'}]}]}], 'analyses': [{'pValue': '0.3367', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'longitudinal repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 169', 'description': "The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.\n\nTotal Score Range (0 = Best outcome and 10 = Worst Outcome)\n\nThe scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Stimulated Whole Salivary Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'categories': [{'measurements': [{'value': '0.057', 'groupId': 'OG000', 'lowerLimit': '-0.115', 'upperLimit': '0.230'}, {'value': '0.108', 'groupId': 'OG001', 'lowerLimit': '-0.060', 'upperLimit': '0.276'}]}]}], 'analyses': [{'pValue': '.5841', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'longitudinal repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 169', 'description': 'The mean change from baseline in the stimulated whole salivary flow at Day 169', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population with Stimulated Whole Salivary Flow of at Least 0.1 mL/min at Both Screening and Baseline'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.2'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.4'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.4'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.6'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.6'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.5'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.7'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.5'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.8'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.6'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.\n\nDAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28) + 0.36 \\* ln(hsCRP+1) + 0.014 \\* VAS + 0.96.\n\n(sqrt = Square root, ln = natural log)\n\nPositive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.3'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '-0.5'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.6'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.7'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '-0.8'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.7'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '-1.0'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.8'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '-1.1'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.9'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-1.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.\n\nDAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28) + 0.36 \\* ln(hsCRP+1) + 0.014 \\* VAS + 0.96.\n\n(sqrt = Square root, ln = natural log)\n\nPositive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population with Baseline Tender plus Swollen Joint Count of at Least 3'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.0'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.1'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.1'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.0'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.0'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.\n\nDAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28) + 0.36 \\* ln(hsCRP+1) + 0.014 \\* VAS + 0.96.\n\n(sqrt = Square root, ln = natural log)\n\nPositive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population with Baseline Tender plus Swollen Joint Count of Less than 3'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '-0.7'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '-0.8'}]}]}, {'title': 'Day 29 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.1'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 57 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '-1.5'}, {'value': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '-1.9'}]}]}, {'title': 'Day 57 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-0.3'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '-0.4'}]}]}, {'title': 'Day 85 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '-1.7'}, {'value': '-3.4', 'groupId': 'OG001', 'lowerLimit': '-4.6', 'upperLimit': '-2.2'}]}]}, {'title': 'Day 85 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-0.8'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '-0.9'}]}]}, {'title': 'Day 113 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '-2.0'}, {'value': '-3.9', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '-2.8'}]}]}, {'title': 'Day 113 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-1.1'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '-1.4'}]}]}, {'title': 'Day 141 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-2.5'}, {'value': '-4.1', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '-3.0'}]}]}, {'title': 'Day 141 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '-0.8'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '-1.3'}]}]}, {'title': 'Day 169 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '-1.7'}, {'value': '-4.4', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '-3.3'}]}]}, {'title': 'Day 169 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '-0.8'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '-1.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nTender Joint: Count 1-28 Swollen Joint: Count 1-28\n\nNegative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted', 'unitOfMeasure': 'Joint Count', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '2.0'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '2.3'}]}]}, {'title': 'Day 57 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '1.8'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '3.6'}]}]}, {'title': 'Day 85 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '4.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '7.6'}]}]}, {'title': 'Day 113 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '4.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '2.6'}]}]}, {'title': 'Day 141 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '8.8'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '4.7'}]}]}, {'title': 'Day 169 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nCRP: measured lab value\n\nPositive Number = Increased level of CRP Negative Number = Reduced Level of CRP', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '1.7'}, {'value': '-7.1', 'groupId': 'OG001', 'lowerLimit': '-12.7', 'upperLimit': '-1.4'}]}]}, {'title': 'Day 57 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'groupId': 'OG000', 'lowerLimit': '-13.4', 'upperLimit': '-1.7'}, {'value': '-6.3', 'groupId': 'OG001', 'lowerLimit': '-11.9', 'upperLimit': '-0.6'}]}]}, {'title': 'Day 85 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.4', 'groupId': 'OG000', 'lowerLimit': '-16.3', 'upperLimit': '-4.4'}, {'value': '-10.2', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '-4.4'}]}]}, {'title': 'Day 113 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'groupId': 'OG000', 'lowerLimit': '-14.0', 'upperLimit': '-2.0'}, {'value': '-9.7', 'groupId': 'OG001', 'lowerLimit': '-15.5', 'upperLimit': '-3.9'}]}]}, {'title': 'Day 141 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'groupId': 'OG000', 'lowerLimit': '-11.0', 'upperLimit': '0.8'}, {'value': '-11.0', 'groupId': 'OG001', 'lowerLimit': '-16.7', 'upperLimit': '-5.3'}]}]}, {'title': 'Day 169 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.1', 'groupId': 'OG000', 'lowerLimit': '-16.1', 'upperLimit': '-4.0'}, {'value': '-9.0', 'groupId': 'OG001', 'lowerLimit': '-14.8', 'upperLimit': '-3.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nAssesment of Disease Activity: 0-100 scale \\[100=Most severe\\]\n\nPositive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '-1.0'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '-1.3'}]}]}, {'title': 'Day 29 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '0.2'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 57 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '-2.3'}, {'value': '-4.8', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '-3.0'}]}]}, {'title': 'Day 57 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '-0.5'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '-0.5'}]}]}, {'title': 'Day 85 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '-2.4'}, {'value': '-5.4', 'groupId': 'OG001', 'lowerLimit': '-7.2', 'upperLimit': '-3.6'}]}]}, {'title': 'Day 85 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '-1.1'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '-1.3'}]}]}, {'title': 'Day 113 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'groupId': 'OG000', 'lowerLimit': '-6.6', 'upperLimit': '-2.9'}, {'value': '-6.0', 'groupId': 'OG001', 'lowerLimit': '-7.7', 'upperLimit': '-4.2'}]}]}, {'title': 'Day 113 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '-1.5'}, {'value': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '-2.2'}]}]}, {'title': 'Day 141 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'groupId': 'OG000', 'lowerLimit': '-7.5', 'upperLimit': '-3.8'}, {'value': '-6.4', 'groupId': 'OG001', 'lowerLimit': '-8.2', 'upperLimit': '-4.7'}]}]}, {'title': 'Day 141 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '-1.3'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '-2.1'}]}]}, {'title': 'Day 169 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.6', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '-2.7'}, {'value': '-6.7', 'groupId': 'OG001', 'lowerLimit': '-8.5', 'upperLimit': '-4.9'}]}]}, {'title': 'Day 169 - 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Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '0.7'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '1.4'}]}]}, {'title': 'Day 57 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '1.7'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '4.0'}]}]}, {'title': 'Day 85 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '5.5'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '11.0'}]}]}, {'title': 'Day 113 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '5.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '3.2'}]}]}, {'title': 'Day 141 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '12.9'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '6.3'}]}]}, {'title': 'Day 169 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '1.1'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nCRP: measured lab value\n\nPositive Number = Increased level of CRP Negative Number = Reduced Level of CRP', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '8.1'}, {'value': '-3.5', 'groupId': 'OG001', 'lowerLimit': '-10.7', 'upperLimit': '3.7'}]}]}, {'title': 'Day 57 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-11.5', 'upperLimit': '4.5'}, {'value': '-6.5', 'groupId': 'OG001', 'lowerLimit': '-14.0', 'upperLimit': '1.1'}]}]}, {'title': 'Day 85 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'groupId': 'OG000', 'lowerLimit': '-15.5', 'upperLimit': '0.4'}, {'value': '-7.7', 'groupId': 'OG001', 'lowerLimit': '-15.3', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 113 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'groupId': 'OG000', 'lowerLimit': '-14.4', 'upperLimit': '1.3'}, {'value': '-9.1', 'groupId': 'OG001', 'lowerLimit': '-16.5', 'upperLimit': '-1.6'}]}]}, {'title': 'Day 141 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '6.7'}, {'value': '-8.1', 'groupId': 'OG001', 'lowerLimit': '-15.5', 'upperLimit': '-0.7'}]}]}, {'title': 'Day 169 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-14.9', 'upperLimit': '1.5'}, {'value': '-7.8', 'groupId': 'OG001', 'lowerLimit': '-15.5', 'upperLimit': '-0.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nAssesment of Disease Activity: 0-100 scale \\[100=Most severe\\]\n\nPositive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '0.6'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '0.6'}]}]}, {'title': 'Day 29 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Day 57 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '0.6'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.9'}]}]}, {'title': 'Day 57 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}]}]}, {'title': 'Day 85 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '0.2'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.8'}]}]}, {'title': 'Day 85 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.2'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Day 113 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '0.3'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '0.3'}]}]}, {'title': 'Day 113 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Day 141 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.6'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.6'}]}]}, {'title': 'Day 141 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.5'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.6'}]}]}, {'title': 'Day 169 - Tender Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '0.7'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '0.1'}]}]}, {'title': 'Day 169 - Swollen Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.5'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nTender Joint: Count 1-28 Swollen Joint: Count 1-28\n\nNegative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted', 'unitOfMeasure': 'Joint Count', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '4.9'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '4.7'}]}]}, {'title': 'Day 57 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '3.4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '3.9'}]}]}, {'title': 'Day 85 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '4.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '3.1'}]}]}, {'title': 'Day 113 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '4.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '3.1'}]}]}, {'title': 'Day 141 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '3.6'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '3.8'}]}]}, {'title': 'Day 169 - CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '3.1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '3.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nCRP: measured lab value\n\nPositive Number = Increased level of CRP Negative Number = Reduced Level of CRP', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'groupId': 'OG000', 'lowerLimit': '-19.3', 'upperLimit': '-1.4'}, {'value': '-11.8', 'groupId': 'OG001', 'lowerLimit': '-21.3', 'upperLimit': '-2.3'}]}]}, {'title': 'Day 57 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.4', 'groupId': 'OG000', 'lowerLimit': '-21.4', 'upperLimit': '-3.4'}, {'value': '-4.8', 'groupId': 'OG001', 'lowerLimit': '-14.3', 'upperLimit': '4.7'}]}]}, {'title': 'Day 85 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'groupId': 'OG000', 'lowerLimit': '-23.0', 'upperLimit': '-5.0'}, {'value': '-13.5', 'groupId': 'OG001', 'lowerLimit': '-23.0', 'upperLimit': '-4.0'}]}]}, {'title': 'Day 113 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.1', 'groupId': 'OG000', 'lowerLimit': '-18.1', 'upperLimit': '-0.0'}, {'value': '-11.1', 'groupId': 'OG001', 'lowerLimit': '-20.6', 'upperLimit': '-1.5'}]}]}, {'title': 'Day 141 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'groupId': 'OG000', 'lowerLimit': '-19.8', 'upperLimit': '-1.5'}, {'value': '-15.3', 'groupId': 'OG001', 'lowerLimit': '-24.8', 'upperLimit': '-5.7'}]}]}, {'title': 'Day 169 - Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.8', 'groupId': 'OG000', 'lowerLimit': '-23.0', 'upperLimit': '-4.6'}, {'value': '-10.9', 'groupId': 'OG001', 'lowerLimit': '-20.5', 'upperLimit': '-1.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nAssesment of Disease Activity: 0-100 scale \\[100=Most severe\\]\n\nPositive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '47.7'}, {'value': '34.7', 'groupId': 'OG001', 'lowerLimit': '25.3', 'upperLimit': '45.2'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '47.7'}, {'value': '44.2', 'groupId': 'OG001', 'lowerLimit': '34.0', 'upperLimit': '54.8'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '38.3', 'upperLimit': '59.6'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '60.9'}]}]}, {'title': 'Day 113', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000', 'lowerLimit': '44.7', 'upperLimit': '65.8'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '60.9'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '61.7'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '67.0'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000', 'lowerLimit': '44.7', 'upperLimit': '65.8'}, {'value': '57.9', 'groupId': 'OG001', 'lowerLimit': '47.3', 'upperLimit': '68.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'Proportion of participants who achieve a minimally clinically important change (of at least 3 points) in the ESSDAI at all measured time points up to Day 169.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '29.1'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '22.3'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '36.3'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '34.1'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '45.4'}, {'value': '32.6', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '43.0'}]}]}, {'title': 'Day 113', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '47.7'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '47.4'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '47.7'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '51.6'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '46.5'}, {'value': '46.3', 'groupId': 'OG001', 'lowerLimit': '36.0', 'upperLimit': '56.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'Proportion of participants who achieve a minimally clinically important change (of at least 5 points) in the ESSDAI at all measured time points up to Day 169.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '42.0'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '29.1', 'upperLimit': '49.5'}]}]}, {'title': 'Day 57', 'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '53.1'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '37.0', 'upperLimit': '57.9'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000', 'lowerLimit': '34.2', 'upperLimit': '55.3'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '45.2', 'upperLimit': '66.0'}]}]}, {'title': 'Day 113', 'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '53.1'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '63.0'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '51.0'}, {'value': '54.7', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '65.0'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '52.1'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '63.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'Proportion of participants who achieve a minimally clinically important change (of at least 1 point) in the ESSPRI at all measured time points up to Day 169.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at All Measured Time Points in the ESSDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.9', 'groupId': 'OG000', 'lowerLimit': '-22.3', 'upperLimit': '0.54'}, {'value': '-12.6', 'groupId': 'OG001', 'lowerLimit': '-23.71', 'upperLimit': '-1.39'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.1', 'groupId': 'OG000', 'lowerLimit': '-36.10', 'upperLimit': '-12.08'}, {'value': '-18.9', 'groupId': 'OG001', 'lowerLimit': '-30.52', 'upperLimit': '-7.32'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.0', 'groupId': 'OG000', 'lowerLimit': '-38.81', 'upperLimit': '-13.17'}, {'value': '-25.4', 'groupId': 'OG001', 'lowerLimit': '-37.76', 'upperLimit': '-13.01'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.1', 'groupId': 'OG000', 'lowerLimit': '-46.8', 'upperLimit': '-21.34'}, {'value': '-32.1', 'groupId': 'OG001', 'lowerLimit': '-44.35', 'upperLimit': '-19.83'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.7', 'groupId': 'OG000', 'lowerLimit': '-43.02', 'upperLimit': '-16.31'}, {'value': '-37.0', 'groupId': 'OG001', 'lowerLimit': '-49.81', 'upperLimit': '-24.12'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.4', 'groupId': 'OG000', 'lowerLimit': '-46.54', 'upperLimit': '-20.24'}, {'value': '-37.6', 'groupId': 'OG001', 'lowerLimit': '-50.24', 'upperLimit': '-25.02'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': "The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.\n\nThe EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.\n\nDomain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)\n\n(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)\n\nOverall score, which can range from 0 to 123, a higher score indicates more disease activity", 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at All Measured Time Points in the ESSPRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '0.16'}, {'value': '-0.54', 'groupId': 'OG001', 'lowerLimit': '-1.00', 'upperLimit': '-0.08'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '-0.31'}, {'value': '-0.82', 'groupId': 'OG001', 'lowerLimit': '-1.31', 'upperLimit': '-0.33'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'groupId': 'OG000', 'lowerLimit': '-1.34', 'upperLimit': '-0.32'}, {'value': '-1.20', 'groupId': 'OG001', 'lowerLimit': '-1.70', 'upperLimit': '-0.70'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '-0.26'}, {'value': '-1.37', 'groupId': 'OG001', 'lowerLimit': '-1.88', 'upperLimit': '-0.86'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'groupId': 'OG000', 'lowerLimit': '-1.40', 'upperLimit': '-0.35'}, {'value': '-1.32', 'groupId': 'OG001', 'lowerLimit': '-1.83', 'upperLimit': '-0.81'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.03', 'groupId': 'OG000', 'lowerLimit': '-1.55', 'upperLimit': '-0.50'}, {'value': '-1.30', 'groupId': 'OG001', 'lowerLimit': '-1.80', 'upperLimit': '-0.79'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': "The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.\n\nTotal Score Range (0 = Best outcome and 10 = Worst Outcome)\n\nThe scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Components of ESSDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29: Constitutional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '-0.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 29: Lymphadenopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '-0.2'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 29: Glandular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.0'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.0'}]}]}, {'title': 'Day 29: Articular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '0.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.1'}]}]}, {'title': 'Day 29: Cutaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.0'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.1'}]}]}, {'title': 'Day 29: Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Day 29: Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.0'}]}]}, {'title': 'Day 29: Muscular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Day 29: Peripheral Nervous System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.20'}]}]}, {'title': 'Day 29: Haematogical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '0.4'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}, {'title': 'Day 29: Biological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.3'}]}]}, {'title': 'Day 57: Constitutional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '-0.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 57: Lymphadenopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 57: Glandular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.2'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 57: Articular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.3'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.4'}]}]}, {'title': 'Day 57: Cutaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.0'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.1'}]}]}, {'title': 'Day 57: Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.5'}]}]}, {'title': 'Day 57: Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}]}]}, {'title': 'Day 57: Muscular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '-0.0'}]}]}, {'title': 'Day 57: Peripheral Nervous System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}, {'title': 'Day 57: Haematological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Day 57: Biological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}, {'title': 'Day 85: Constitutional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 85: Lymphadenopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.3'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.4'}]}]}, {'title': 'Day 85: Glandular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.1'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 85: Articular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.6'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '-0.7'}]}]}, {'title': 'Day 85: Cutaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.0'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.1'}]}]}, {'title': 'Day 85: Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.4'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.5'}]}]}, {'title': 'Day 85: Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}]}]}, {'title': 'Day 85: Muscular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.0'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}, {'title': 'Day 85: Peripheral Nervous System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}, {'title': 'Day 85: Haematological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}, {'title': 'Day 85: Biological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.3'}]}]}, {'title': 'Day 113: Constitutional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.0'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 113: Lymphadenopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '-0.4'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.5'}]}]}, {'title': 'Day 113: Glandular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.3'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '-0.3'}]}]}, {'title': 'Day 113: Articular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '-0.8'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '-0.8'}]}]}, {'title': 'Day 113: Cutaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.1'}]}]}, {'title': 'Day 113: Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.4'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.5'}]}]}, {'title': 'Day 113: Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}, {'title': 'Day 113: Muscular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.0'}]}]}, {'title': 'Day 113: Peripheral Nervous System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}]}]}, {'title': 'Day 113: Haematological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Day 113: Biological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.3'}]}]}, {'title': 'Day 141: Constitutional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.0'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 141: Lymphadenopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.2'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.5'}]}]}, {'title': 'Day 141: Glandular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '-0.4'}]}]}, {'title': 'Day 141: Articular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.8'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-1.0'}]}]}, {'title': 'Day 141: Cutaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.1'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '-0.3'}]}]}, {'title': 'Day 141: Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Day 141: Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}]}]}, {'title': 'Day 141: Muscular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.0'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.0'}]}]}, {'title': 'Day 141: Peripheral Nervous System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}]}]}, {'title': 'Day 141: Haematological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}, {'title': 'Day 141: Biological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.2'}]}]}, {'title': 'Day 169: Constitutional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 169: Lymphadenopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-0.5'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.7'}]}]}, {'title': 'Day 169: Glandular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.1'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '-0.3'}]}]}, {'title': 'Day 169: Articular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '-0.9'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '-1.4'}]}]}, {'title': 'Day 169: Cutaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '0.0'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.2'}]}]}, {'title': 'Day 169: Pulmonary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Day 169: Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}, {'title': 'Day 169: Muscular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.0'}]}]}, {'title': 'Day 169: Peripheral Nervous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}, {'title': 'Day 169: Haematological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.5'}]}]}, {'title': 'Day 169: Biological', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169', 'description': "The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.\n\nThe EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.\n\nDomain: (Score for activity level) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)\n\n(No = No Disease Activity, Low = Low Disease Activity, Moderate = Moderate Disease Activity, High = High Disease Activity)", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ESSPRI Components', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29: Dryness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-0.76', 'upperLimit': '0.34'}, {'value': '-0.26', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '0.28'}]}]}, {'title': 'Day 29: Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'groupId': 'OG000', 'lowerLimit': '-1.18', 'upperLimit': '0.03'}, {'value': '-1.01', 'groupId': 'OG001', 'lowerLimit': '-1.60', 'upperLimit': '-0.42'}]}]}, {'title': 'Day 29: Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '0.27'}, {'value': '-0.53', 'groupId': 'OG001', 'lowerLimit': '-1.13', 'upperLimit': '0.07'}]}]}, {'title': 'Day 57: Dryness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'groupId': 'OG000', 'lowerLimit': '-1.51', 'upperLimit': '-0.33'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-1.09', 'upperLimit': '0.05'}]}]}, {'title': 'Day 57: Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'groupId': 'OG000', 'lowerLimit': '-1.70', 'upperLimit': '-0.48'}, {'value': '-1.22', 'groupId': 'OG001', 'lowerLimit': '-1.81', 'upperLimit': '-0.63'}]}]}, {'title': 'Day 57: Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG000', 'lowerLimit': '-1.24', 'upperLimit': '0.05'}, {'value': '-0.90', 'groupId': 'OG001', 'lowerLimit': '-1.52', 'upperLimit': '-0.27'}]}]}, {'title': 'Day 85: Dryness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.68', 'groupId': 'OG000', 'lowerLimit': '-1.25', 'upperLimit': '-0.11'}, {'value': '-0.91', 'groupId': 'OG001', 'lowerLimit': '-1.46', 'upperLimit': '-0.36'}]}]}, {'title': 'Day 85: Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.27', 'groupId': 'OG000', 'lowerLimit': '-1.91', 'upperLimit': '-0.63'}, {'value': '-1.56', 'groupId': 'OG001', 'lowerLimit': '-2.18', 'upperLimit': '-0.94'}]}]}, {'title': 'Day 85: Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'groupId': 'OG000', 'lowerLimit': '-1.35', 'upperLimit': '-0.05'}, {'value': '-1.31', 'groupId': 'OG001', 'lowerLimit': '-1.93', 'upperLimit': '-0.68'}]}]}, {'title': 'Day 113: Dryness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.74', 'groupId': 'OG000', 'lowerLimit': '-1.36', 'upperLimit': '-0.12'}, {'value': '-1.19', 'groupId': 'OG001', 'lowerLimit': '-1.79', 'upperLimit': '-0.60'}]}]}, {'title': 'Day 113: Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'groupId': 'OG000', 'lowerLimit': '-1.65', 'upperLimit': '-0.39'}, {'value': '-1.76', 'groupId': 'OG001', 'lowerLimit': '-2.37', 'upperLimit': '-1.15'}]}]}, {'title': 'Day 113: Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.76', 'groupId': 'OG000', 'lowerLimit': '-1.40', 'upperLimit': '-0.11'}, {'value': '-1.37', 'groupId': 'OG001', 'lowerLimit': '-1.99', 'upperLimit': '-0.74'}]}]}, {'title': 'Day 141: Dryness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.89', 'groupId': 'OG000', 'lowerLimit': '-1.49', 'upperLimit': '-0.28'}, {'value': '-1.05', 'groupId': 'OG001', 'lowerLimit': '-1.63', 'upperLimit': '-0.46'}]}]}, {'title': 'Day 141: Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'groupId': 'OG000', 'lowerLimit': '-1.83', 'upperLimit': '-0.53'}, {'value': '-1.73', 'groupId': 'OG001', 'lowerLimit': '-2.36', 'upperLimit': '-1.11'}]}]}, {'title': 'Day 141: Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'groupId': 'OG000', 'lowerLimit': '-1.34', 'upperLimit': '-0.07'}, {'value': '-1.39', 'groupId': 'OG001', 'lowerLimit': '-2.00', 'upperLimit': '-0.78'}]}]}, {'title': 'Day 169: Dryness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'groupId': 'OG000', 'lowerLimit': '-1.46', 'upperLimit': '-0.23'}, {'value': '-1.04', 'groupId': 'OG001', 'lowerLimit': '-1.63', 'upperLimit': '-0.44'}]}]}, {'title': 'Day 169: Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'groupId': 'OG000', 'lowerLimit': '-1.93', 'upperLimit': '-0.64'}, {'value': '-1.57', 'groupId': 'OG001', 'lowerLimit': '-2.19', 'upperLimit': '-0.95'}]}]}, {'title': 'Day 169: Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '-0.47'}, {'value': '-1.45', 'groupId': 'OG001', 'lowerLimit': '-2.06', 'upperLimit': '-0.83'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': "The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.\n\nTotal Score Range (0 = Best outcome and 10 = Worst Outcome)\n\nThe scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Schirmer's Test", 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 85: Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '3.9'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '3.5'}]}]}, {'title': 'Day 85: Non-Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '2.2'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '2.9'}]}]}, {'title': 'Day 85: Average of Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '-0.75', 'upperLimit': '2.96'}, {'value': '1.41', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '3.24'}]}]}, {'title': 'Day 169: Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '3.9'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '3.2'}]}]}, {'title': 'Day 169: Non-Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '2.4'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '2.1'}]}]}, {'title': 'Day 169: Average of Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '-0.59', 'upperLimit': '3.00'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '-0.97', 'upperLimit': '2.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 85, Day 169', 'description': "The Mean change from baseline in Schirmer's Test at all measured time points up to day 169\n\nThe length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.", 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Ocular Staining Score (OSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 85: Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-0.9'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '0.3'}]}]}, {'title': 'Day 85: Non-Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '0.2'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '1.2'}]}]}, {'title': 'Day 85: Average of Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'groupId': 'OG000', 'lowerLimit': '-1.91', 'upperLimit': '-0.39'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.81', 'upperLimit': '0.68'}]}]}, {'title': 'Day 169: Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '-0.6'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '0.1'}]}]}, {'title': 'Day 169: Non-Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '0.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '1.2'}]}]}, {'title': 'Day 169: Average of Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.99', 'groupId': 'OG000', 'lowerLimit': '-1.79', 'upperLimit': '-0.19'}, {'value': '-0.19', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '0.60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 85, Day 169', 'description': 'The Mean change from baseline in OSS at all measured time points up to day 169\n\nScore of 0 = No Staining Score of 12 = diffuse staining\n\nThe total score will be calculated as the sum of the score for these parameters for each eye.\n\nMedial Nasal Bulbar Conjunctiva (MNBC) \\[score scale: 0 - 3\\], Corneal (CORN) Staining of Punctate Epithelial Erosions (PEE) \\[score scale: 0 - 3\\], Lateral Temporal Bulbar Conjunctiva (LTBC) \\[score scale: 0 - 3\\], Patches of Confluent Staining (CONF) \\[score scale: 0 - 1\\], PEE observed in the pupil region, i.e. central 4mm diameter portion of the cornea (PUPL) \\[score scale: 0 - 1\\], one of more filaments seen anywhere on the cornea (FILA) \\[score scale: 0 - 1\\]', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Break-up Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 85: Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-0.99', 'upperLimit': '0.73'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '-0.67', 'upperLimit': '1.04'}]}]}, {'title': 'Day 85: Non-Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'groupId': 'OG000', 'lowerLimit': '-1.59', 'upperLimit': '0.18'}, {'value': '-0.12', 'groupId': 'OG001', 'lowerLimit': '-1.01', 'upperLimit': '0.76'}]}]}, {'title': 'Day 85: Average of Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000', 'lowerLimit': '-1.24', 'upperLimit': '0.43'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '-0.74', 'upperLimit': '0.92'}]}]}, {'title': 'Day 169: Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'groupId': 'OG000', 'lowerLimit': '-1.11', 'upperLimit': '0.64'}, {'value': '-0.32', 'groupId': 'OG001', 'lowerLimit': '-1.19', 'upperLimit': '0.56'}]}]}, {'title': 'Day 169: Non-Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'groupId': 'OG000', 'lowerLimit': '-1.62', 'upperLimit': '0.03'}, {'value': '-0.62', 'groupId': 'OG001', 'lowerLimit': '-1.46', 'upperLimit': '0.21'}]}]}, {'title': 'Day 169: Average of Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '0.31'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-1.25', 'upperLimit': '0.39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 85, Day 169', 'description': 'The Mean change from baseline in Tear Break-up Time at all measured time points up to day 169\n\nThe CRF collects the time in seconds to first appearance of a random dry spot on the corneal surface for 3 repetitions in each eye. The average time will calculated for each eye averaging the 3 measurements for each eye separately. In case only 2 measurements are available, the average of the 2 measurements will be calculated. In case there is only 1 measurement, that measurement will be used for the analysis.', 'unitOfMeasure': 'Seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Unstimulated Salivary Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.106', 'groupId': 'OG000', 'lowerLimit': '-0.037', 'upperLimit': '0.249'}, {'value': '0.158', 'groupId': 'OG001', 'lowerLimit': '0.022', 'upperLimit': '0295'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.051', 'groupId': 'OG000', 'lowerLimit': '-0.100', 'upperLimit': '0.203'}, {'value': '0.105', 'groupId': 'OG001', 'lowerLimit': '-0.042', 'upperLimit': '0.251'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 85, Day 169', 'description': 'The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Stimulated Salivary Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '-0.039', 'upperLimit': '0.262'}, {'value': '0.169', 'groupId': 'OG001', 'lowerLimit': '0.024', 'upperLimit': '0.314'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.056', 'groupId': 'OG000', 'lowerLimit': '-0.104', 'upperLimit': '0.216'}, {'value': '0.108', 'groupId': 'OG001', 'lowerLimit': '-0.048', 'upperLimit': '0.263'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 85, Day 169', 'description': 'The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Numeric Rating Scale for Mouth Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '3'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '6'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '5'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '6'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '4'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '8'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '3'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '4'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '5'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '6'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '3'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 29, 57, 85, 113, 141, 169', 'description': 'The mean change from baseline in participant symptoms using the Numeric Rating Scale (NRS) for mouth dryness at all measured time points up to Day 169.\n\nThe oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Numeric Rating Scale for Eye Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '5'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '5'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '5'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '5'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '6'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '8'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '7'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '4'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '7'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '4'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '6'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 29, 57, 85, 113, 141, 169', 'description': 'The mean change from baseline in patient symptoms using the Numeric Rating Scale (NRS) for eye dryness at all measured time points up to Day 169.\n\nThe oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '1.7'}, {'value': '-7.1', 'groupId': 'OG001', 'lowerLimit': '-12.7', 'upperLimit': '-1.4'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'groupId': 'OG000', 'lowerLimit': '-13.4', 'upperLimit': '-1.7'}, {'value': '-6.3', 'groupId': 'OG001', 'lowerLimit': '-11.9', 'upperLimit': '-0.6'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.4', 'groupId': 'OG000', 'lowerLimit': '-16.3', 'upperLimit': '-4.4'}, {'value': '-10.2', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '-4.4'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'groupId': 'OG000', 'lowerLimit': '-14.0', 'upperLimit': '-2.0'}, {'value': '-9.7', 'groupId': 'OG001', 'lowerLimit': '-15.5', 'upperLimit': '-3.9'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'groupId': 'OG000', 'lowerLimit': '-11.0', 'upperLimit': '0.8'}, {'value': '-11.0', 'groupId': 'OG001', 'lowerLimit': '-16.7', 'upperLimit': '-5.3'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.1', 'groupId': 'OG000', 'lowerLimit': '-16.1', 'upperLimit': '-4.0'}, {'value': '-9.0', 'groupId': 'OG001', 'lowerLimit': '-14.8', 'upperLimit': '-3.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, 57, 85, 113, 141, 169', 'description': 'The participant global assessment of disease activity are assessed with visual analog scales. The participant marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.\n\nIn cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:\n\nRescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) \\* 100mm\n\nA negative score = participant assessment of disease activity has improved\n\nA positive score = participant assessment of disease activity has worsened', 'unitOfMeasure': 'Score on VAS 0-100mm scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physician Global Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'groupId': 'OG000', 'lowerLimit': '-14.8', 'upperLimit': '-5.8'}, {'value': '-10.5', 'groupId': 'OG001', 'lowerLimit': '-14.9', 'upperLimit': '-6.1'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.2', 'groupId': 'OG000', 'lowerLimit': '-20.8', 'upperLimit': '-11.7'}, {'value': '-16.7', 'groupId': 'OG001', 'lowerLimit': '-21.1', 'upperLimit': '-12.3'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'groupId': 'OG000', 'lowerLimit': '-25.6', 'upperLimit': '-16.0'}, {'value': '-19.4', 'groupId': 'OG001', 'lowerLimit': '-24.0', 'upperLimit': '-14.7'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.8', 'groupId': 'OG000', 'lowerLimit': '-27.9', 'upperLimit': '-17.8'}, {'value': '-19.8', 'groupId': 'OG001', 'lowerLimit': '-24.6', 'upperLimit': '-14.9'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.7', 'groupId': 'OG000', 'lowerLimit': '-28.6', 'upperLimit': '-18.8'}, {'value': '-21.7', 'groupId': 'OG001', 'lowerLimit': '-26.5', 'upperLimit': '-17.0'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.0', 'groupId': 'OG000', 'lowerLimit': '-27.8', 'upperLimit': '-18.2'}, {'value': '-23.7', 'groupId': 'OG001', 'lowerLimit': '-28.3', 'upperLimit': '-19.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, 57, 85, 113, 141, 169', 'description': 'The physician global assessment of disease activity are assessed with visual analog scales. The physician marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.\n\nIn cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:\n\nRescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) \\* 100mm\n\nA negative score = physician assessment of disease activity has improved\n\nA positive score = physician assessment of disease activity has worsened', 'unitOfMeasure': 'Score on VAS 0-100mm Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.08', 'groupId': 'OG000', 'lowerLimit': '-5.22', 'upperLimit': '-0.95'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-6.09', 'upperLimit': '-1.88'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.12', 'groupId': 'OG000', 'lowerLimit': '-6.27', 'upperLimit': '-1.97'}, {'value': '-4.02', 'groupId': 'OG001', 'lowerLimit': '-6.12', 'upperLimit': '-1.91'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.85', 'groupId': 'OG000', 'lowerLimit': '-7.05', 'upperLimit': '-2.64'}, {'value': '-5.48', 'groupId': 'OG001', 'lowerLimit': '-7.64', 'upperLimit': '-3.32'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'groupId': 'OG000', 'lowerLimit': '-6.37', 'upperLimit': '-1.97'}, {'value': '-5.32', 'groupId': 'OG001', 'lowerLimit': '-7.48', 'upperLimit': '-3.17'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.84', 'groupId': 'OG000', 'lowerLimit': '-7.06', 'upperLimit': '-2.62'}, {'value': '-5.68', 'groupId': 'OG001', 'lowerLimit': '-7.85', 'upperLimit': '-3.52'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'groupId': 'OG000', 'lowerLimit': '-7.83', 'upperLimit': '-3.28'}, {'value': '-5.59', 'groupId': 'OG001', 'lowerLimit': '-7.82', 'upperLimit': '-3.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29, 57, 85, 113, 141, 169', 'description': 'The mean change from baseline in patient fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue assessment of disease activity at all measured time points up to Day 169.\n\nPROMIS Fatigue instruments 10 Questions ranging from a score 0 to 40. Sum of the values gives you the raw sum. The raw is inputted into this formula to give you the raw score:\n\nRaw Score = (Raw sum\\*number of items on the short form)/(Number of items that were actually answered)\n\nRaw score is translated to a T-Score using a table. T-Score is used as the final score.\n\nThe T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The standardized T-score is reported as the final score for each participant.\n\nA negative T Score = Better Prognosis A positive T Score = Worse prognosis', 'unitOfMeasure': 'T-Score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'groupId': 'OG000', 'lowerLimit': '-5.67', 'upperLimit': '0.78'}, {'value': '-1.56', 'groupId': 'OG001', 'lowerLimit': '-4.90', 'upperLimit': '1.77'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.32', 'groupId': 'OG000', 'lowerLimit': '-5.73', 'upperLimit': '1.09'}, {'value': '-1.87', 'groupId': 'OG001', 'lowerLimit': '-5.42', 'upperLimit': '1.68'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 85, Day 169', 'description': 'For the FSFI, is a 19 item instrument used for assessing key dimensions of female sexual function over the past 4 weeks with 6 domains being analyzed. The specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI are scored on a scale ranging from 0 to 5, with higher scores indicating better performance. Domain scores are calculated by summing the scores of the individual questions that make up the domain and multiplying the sum by the factor in the table below. The full scale score is the sum of the six domain scores.\n\nFull Scale Score range: 2.0(minimum score) - 36.0 (maximum score)\n\nNegative Score = Reduced functioning Positive Score = Improved functioning', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item Short Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 85: Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.908', 'groupId': 'OG000', 'lowerLimit': '-0.240', 'upperLimit': '4.056'}, {'value': '1.523', 'groupId': 'OG001', 'lowerLimit': '-0.568', 'upperLimit': '3.614'}]}]}, {'title': 'Day 85: Role Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.248', 'groupId': 'OG000', 'lowerLimit': '3.112', 'upperLimit': '7.383'}, {'value': '4.416', 'groupId': 'OG001', 'lowerLimit': '2.321', 'upperLimit': '6.511'}]}]}, {'title': 'Day 85: Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.200', 'groupId': 'OG000', 'lowerLimit': '0.910', 'upperLimit': '5.490'}, {'value': '3.721', 'groupId': 'OG001', 'lowerLimit': '1.464', 'upperLimit': '5.978'}]}]}, {'title': 'Day 85: General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.042', 'groupId': 'OG000', 'lowerLimit': '1.938', 'upperLimit': '6.146'}, {'value': '3.409', 'groupId': 'OG001', 'lowerLimit': '1.363', 'upperLimit': '5.456'}]}]}, {'title': 'Day 85: Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.827', 'groupId': 'OG000', 'lowerLimit': '1.269', 'upperLimit': '6.384'}, {'value': '3.859', 'groupId': 'OG001', 'lowerLimit': '1.335', 'upperLimit': '6.382'}]}]}, {'title': 'Day 85: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.020', 'groupId': 'OG000', 'lowerLimit': '0.296', 'upperLimit': '5.744'}, {'value': '4.771', 'groupId': 'OG001', 'lowerLimit': '2.117', 'upperLimit': '7.426'}]}]}, {'title': 'Day 85: Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.024', 'groupId': 'OG000', 'lowerLimit': '0.214', 'upperLimit': '5.834'}, {'value': '4.834', 'groupId': 'OG001', 'lowerLimit': '2.093', 'upperLimit': '7.576'}]}]}, {'title': 'Day 85: Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.942', 'groupId': 'OG000', 'lowerLimit': '0.458', 'upperLimit': '5.425'}, {'value': '2.287', 'groupId': 'OG001', 'lowerLimit': '-0.135', 'upperLimit': '4.709'}]}]}, {'title': 'Day 85: Physical component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.430', 'groupId': 'OG000', 'lowerLimit': '1.615', 'upperLimit': '5.244'}, {'value': '2.686', 'groupId': 'OG001', 'lowerLimit': '0.904', 'upperLimit': '4.468'}]}]}, {'title': 'Day 85: Mental component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.693', 'groupId': 'OG000', 'lowerLimit': '0.160', 'upperLimit': '5.226'}, {'value': '3.672', 'groupId': 'OG001', 'lowerLimit': '1.208', 'upperLimit': '6.136'}]}]}, {'title': 'Day 169: Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.927', 'groupId': 'OG000', 'lowerLimit': '0.593', 'upperLimit': '5.261'}, {'value': '1.742', 'groupId': 'OG001', 'lowerLimit': '-0.505', 'upperLimit': '3.989'}]}]}, {'title': 'Day 169: Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.853', 'groupId': 'OG000', 'lowerLimit': '3.756', 'upperLimit': '7.949'}, {'value': '4.626', 'groupId': 'OG001', 'lowerLimit': '2.604', 'upperLimit': '6.649'}]}]}, {'title': 'Day 169: Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.842', 'groupId': 'OG000', 'lowerLimit': '1.432', 'upperLimit': '6.252'}, {'value': '3.458', 'groupId': 'OG001', 'lowerLimit': '1.114', 'upperLimit': '5.801'}]}]}, {'title': 'Day 169: General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.880', 'groupId': 'OG000', 'lowerLimit': '1.700', 'upperLimit': '6.060'}, {'value': '3.764', 'groupId': 'OG001', 'lowerLimit': '1.665', 'upperLimit': '5.862'}]}]}, {'title': 'Day 169: Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.742', 'groupId': 'OG000', 'lowerLimit': '1.160', 'upperLimit': '6.324'}, {'value': '4.523', 'groupId': 'OG001', 'lowerLimit': '2.005', 'upperLimit': '7.041'}]}]}, {'title': 'Day 169: Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.125', 'groupId': 'OG000', 'lowerLimit': '1.320', 'upperLimit': '6.929'}, {'value': '4.471', 'groupId': 'OG001', 'lowerLimit': '1.773', 'upperLimit': '7.169'}]}]}, {'title': 'Day 169: Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.653', 'groupId': 'OG000', 'lowerLimit': '1.943', 'upperLimit': '7.364'}, {'value': '4.930', 'groupId': 'OG001', 'lowerLimit': '2.334', 'upperLimit': '7.526'}]}]}, {'title': 'Day 169: Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.375', 'groupId': 'OG000', 'lowerLimit': '-0.116', 'upperLimit': '4.866'}, {'value': '2.972', 'groupId': 'OG001', 'lowerLimit': '0.581', 'upperLimit': '5.363'}]}]}, {'title': 'Day 169: Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.998', 'groupId': 'OG000', 'lowerLimit': '2.045', 'upperLimit': '5.951'}, {'value': '2.650', 'groupId': 'OG001', 'lowerLimit': '0.756', 'upperLimit': '4.543'}]}]}, {'title': 'Day 169: Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.940', 'groupId': 'OG000', 'lowerLimit': '0.368', 'upperLimit': '5.512'}, {'value': '4.112', 'groupId': 'OG001', 'lowerLimit': '1.648', 'upperLimit': '6.577'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 85, Day 169', 'description': "The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.\n\nScores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT Population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean of Trough Concentration (Cmin) of Abatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.401', 'spread': '36', 'groupId': 'OG000'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.543', 'spread': '38.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.567', 'spread': '42.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.870', 'spread': '40.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.522', 'spread': '42.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29, 85, 113, 141, 169', 'description': 'Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Evaluable Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Positive Antibody Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Study Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Post Treatment Day 85 (DB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Post Treatment Day 169 (DB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 85 db, day 169 db, post treatment day 85', 'description': 'Percentage of participants with at least one positive immunogenicity response up to Day 169 and during 3 months follow up (for participants who discontinue during the 6-months double-blind).', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Analysis Population'}, {'type': 'SECONDARY', 'title': 'Summary of Adverse Events: Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}, {'value': '71.6', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuation due to AEs', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.', 'description': 'Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'As-Treated Population'}, {'type': 'SECONDARY', 'title': 'Laboratory Marked Abnormalities: Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'OG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Hematocrit High', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin High', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes high', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes low', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Basophils high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Basophils Low', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils High', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils Low', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'lymphocytes high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'lymphocytes low', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes Low', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils+Bands High', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils+Bands Low', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase High', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase HIgh', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase High', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Total High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'G-Glutamyl Transferase High', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen High', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Low', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chloride High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chloride Low', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Low', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Low', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Serum High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Serum Low', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Albumin High', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Low', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Protein, Total High', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Protein, Total Low', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Blood, Urine High', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Blood, Urine Low', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Urine High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Urine Low', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Protein, Urine High', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.', 'description': 'Laboratory values meeting the marked abnormality criteria', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'As-Treated Analysis Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept 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Adverse Events: Cumulative Abatacept Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cumulative Treatment Period', 'description': 'Cumulative Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to AEs', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Related Serious Adverse Events', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Discontinued due to SAEs', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 and 3 months of follow up approximately 450 Days', 'description': 'Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Cumulative Abatacept Population'}, {'type': 'SECONDARY', 'title': 'Laboratory Marked Abnormalities: Cumulative Abatacept Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cumulative Open Label Treatment Period', 'description': 'Cumulative Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}], 'classes': [{'title': 'Hematocrit High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': 'Basophils high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Basophils Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'lymphocytes high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'lymphocytes low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils+Bands High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils+Bands Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase HIgh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Total High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'G-Glutamyl Transferase High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Blood Urea Nitrogen High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Calcium High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Chloride High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Potassium High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Potassium Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Sodium High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Sodium Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Serum High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Serum Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Albumin High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Albumin Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Total High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Total Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Creatine Kinase High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Blood, Urine High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'Blood, Urine Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Urine High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Urine Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Urine High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'WBC, Urine High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 and 3 months of follow up approximately 450 Days', 'description': 'Laboratory values meeting the marked abnormality criteria', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Cumulative Abatacept Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'FG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Participant no longer meets criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Request to discontinue treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '250 enrolled; 188 Randomized, 62 not Randomized:Reasons Not randomized: 6 withdrew consent, 1 lost to follow-up, 49 no longer meet study criteria, 6 screening failures'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abatacept - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe'}, {'id': 'BG001', 'title': 'Placebo - Double Blind Treatment Period', 'description': 'Double Blind Treatment Period SC injection in 1 mL pre-filled syringe'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '52.9', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '52.0', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': '≤ 50 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': '> 50 years', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Categorical Age Dispersion', 'unitOfMeasure': 'Participants', 'populationDescription': 'Total Participants will = 187 total participants, when the two values assessing the variation in the 65 years group are summed up as well as the two values assessing the variation in the 50 years group are summed up.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-17', 'size': 10156017, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-07T13:54', 'hasProtocol': False}, {'date': '2016-08-25', 'size': 9251550, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-31T16:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2016-09-23', 'resultsFirstSubmitDate': '2019-08-07', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-13', 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)", 'timeFrame': 'Day 169', 'description': "The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.\n\nThe EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.\n\nDomain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)\n\n(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)\n\nOverall score, which can range from 0 to 123, a higher score indicates more disease activity"}], 'secondaryOutcomes': [{'measure': "Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)", 'timeFrame': 'Day 169', 'description': "The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.\n\nTotal Score Range (0 = Best outcome and 10 = Worst Outcome)\n\nThe scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains."}, {'measure': 'Change From Baseline in the Stimulated Whole Salivary Flow', 'timeFrame': 'Day 169', 'description': 'The mean change from baseline in the stimulated whole salivary flow at Day 169'}, {'measure': 'Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.\n\nDAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28) + 0.36 \\* ln(hsCRP+1) + 0.014 \\* VAS + 0.96.\n\n(sqrt = Square root, ln = natural log)\n\nPositive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity'}, {'measure': 'Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.\n\nDAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28) + 0.36 \\* ln(hsCRP+1) + 0.014 \\* VAS + 0.96.\n\n(sqrt = Square root, ln = natural log)\n\nPositive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity'}, {'measure': 'Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.\n\nDAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28) + 0.36 \\* ln(hsCRP+1) + 0.014 \\* VAS + 0.96.\n\n(sqrt = Square root, ln = natural log)\n\nPositive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity'}, {'measure': 'Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nTender Joint: Count 1-28 Swollen Joint: Count 1-28\n\nNegative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted'}, {'measure': 'Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nCRP: measured lab value\n\nPositive Number = Increased level of CRP Negative Number = Reduced Level of CRP'}, {'measure': 'Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nAssesment of Disease Activity: 0-100 scale \\[100=Most severe\\]\n\nPositive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity'}, {'measure': 'Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nTender Joint: Count 1-28 Swollen Joint: Count 1-28\n\nNegative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted'}, {'measure': 'Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nCRP: measured lab value\n\nPositive Number = Increased level of CRP Negative Number = Reduced Level of CRP'}, {'measure': 'Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nAssesment of Disease Activity: 0-100 scale \\[100=Most severe\\]\n\nPositive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity'}, {'measure': 'Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nTender Joint: Count 1-28 Swollen Joint: Count 1-28\n\nNegative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted'}, {'measure': 'Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nCRP: measured lab value\n\nPositive Number = Increased level of CRP Negative Number = Reduced Level of CRP'}, {'measure': 'Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.\n\nAssesment of Disease Activity: 0-100 scale \\[100=Most severe\\]\n\nPositive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity'}, {'measure': 'Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'Proportion of participants who achieve a minimally clinically important change (of at least 3 points) in the ESSDAI at all measured time points up to Day 169.'}, {'measure': 'Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'Proportion of participants who achieve a minimally clinically important change (of at least 5 points) in the ESSDAI at all measured time points up to Day 169.'}, {'measure': 'Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': 'Proportion of participants who achieve a minimally clinically important change (of at least 1 point) in the ESSPRI at all measured time points up to Day 169.'}, {'measure': 'Change From Baseline at All Measured Time Points in the ESSDAI', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': "The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.\n\nThe EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.\n\nDomain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)\n\n(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)\n\nOverall score, which can range from 0 to 123, a higher score indicates more disease activity"}, {'measure': 'Change From Baseline at All Measured Time Points in the ESSPRI', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': "The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.\n\nTotal Score Range (0 = Best outcome and 10 = Worst Outcome)\n\nThe scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains."}, {'measure': 'Change From Baseline in Components of ESSDAI', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169', 'description': "The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.\n\nThe EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.\n\nDomain: (Score for activity level) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)\n\n(No = No Disease Activity, Low = Low Disease Activity, Moderate = Moderate Disease Activity, High = High Disease Activity)"}, {'measure': 'Change From Baseline in ESSPRI Components', 'timeFrame': 'Day 29, Day 57, Day 85, Day 113, Day 141, Day 169', 'description': "The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.\n\nTotal Score Range (0 = Best outcome and 10 = Worst Outcome)\n\nThe scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains."}, {'measure': "Change From Baseline in Schirmer's Test", 'timeFrame': 'Day 85, Day 169', 'description': "The Mean change from baseline in Schirmer's Test at all measured time points up to day 169\n\nThe length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye."}, {'measure': 'Change From Baseline in the Ocular Staining Score (OSS)', 'timeFrame': 'Day 85, Day 169', 'description': 'The Mean change from baseline in OSS at all measured time points up to day 169\n\nScore of 0 = No Staining Score of 12 = diffuse staining\n\nThe total score will be calculated as the sum of the score for these parameters for each eye.\n\nMedial Nasal Bulbar Conjunctiva (MNBC) \\[score scale: 0 - 3\\], Corneal (CORN) Staining of Punctate Epithelial Erosions (PEE) \\[score scale: 0 - 3\\], Lateral Temporal Bulbar Conjunctiva (LTBC) \\[score scale: 0 - 3\\], Patches of Confluent Staining (CONF) \\[score scale: 0 - 1\\], PEE observed in the pupil region, i.e. central 4mm diameter portion of the cornea (PUPL) \\[score scale: 0 - 1\\], one of more filaments seen anywhere on the cornea (FILA) \\[score scale: 0 - 1\\]'}, {'measure': 'Change From Baseline in Tear Break-up Time', 'timeFrame': 'Day 85, Day 169', 'description': 'The Mean change from baseline in Tear Break-up Time at all measured time points up to day 169\n\nThe CRF collects the time in seconds to first appearance of a random dry spot on the corneal surface for 3 repetitions in each eye. The average time will calculated for each eye averaging the 3 measurements for each eye separately. In case only 2 measurements are available, the average of the 2 measurements will be calculated. In case there is only 1 measurement, that measurement will be used for the analysis.'}, {'measure': 'Change From Baseline in Unstimulated Salivary Flow', 'timeFrame': 'Day 85, Day 169', 'description': 'The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.'}, {'measure': 'Change From Baseline in Stimulated Salivary Flow', 'timeFrame': 'Day 85, Day 169', 'description': 'The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.'}, {'measure': 'Change From Baseline in Numeric Rating Scale for Mouth Dryness', 'timeFrame': 'Day 1, 29, 57, 85, 113, 141, 169', 'description': 'The mean change from baseline in participant symptoms using the Numeric Rating Scale (NRS) for mouth dryness at all measured time points up to Day 169.\n\nThe oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness'}, {'measure': 'Change From Baseline in Numeric Rating Scale for Eye Dryness', 'timeFrame': 'Day 1, 29, 57, 85, 113, 141, 169', 'description': 'The mean change from baseline in patient symptoms using the Numeric Rating Scale (NRS) for eye dryness at all measured time points up to Day 169.\n\nThe oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness'}, {'measure': 'Change From Baseline in Participant Assessment of Disease Activity', 'timeFrame': 'Day 29, 57, 85, 113, 141, 169', 'description': 'The participant global assessment of disease activity are assessed with visual analog scales. The participant marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.\n\nIn cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:\n\nRescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) \\* 100mm\n\nA negative score = participant assessment of disease activity has improved\n\nA positive score = participant assessment of disease activity has worsened'}, {'measure': 'Change From Baseline in Physician Global Assessment of Disease Activity', 'timeFrame': 'Day 29, 57, 85, 113, 141, 169', 'description': 'The physician global assessment of disease activity are assessed with visual analog scales. The physician marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.\n\nIn cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:\n\nRescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) \\* 100mm\n\nA negative score = physician assessment of disease activity has improved\n\nA positive score = physician assessment of disease activity has worsened'}, {'measure': 'Change From Baseline in Patient Fatigue', 'timeFrame': 'Day 29, 57, 85, 113, 141, 169', 'description': 'The mean change from baseline in patient fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue assessment of disease activity at all measured time points up to Day 169.\n\nPROMIS Fatigue instruments 10 Questions ranging from a score 0 to 40. Sum of the values gives you the raw sum. The raw is inputted into this formula to give you the raw score:\n\nRaw Score = (Raw sum\\*number of items on the short form)/(Number of items that were actually answered)\n\nRaw score is translated to a T-Score using a table. T-Score is used as the final score.\n\nThe T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The standardized T-score is reported as the final score for each participant.\n\nA negative T Score = Better Prognosis A positive T Score = Worse prognosis'}, {'measure': 'Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)', 'timeFrame': 'Day 85, Day 169', 'description': 'For the FSFI, is a 19 item instrument used for assessing key dimensions of female sexual function over the past 4 weeks with 6 domains being analyzed. The specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI are scored on a scale ranging from 0 to 5, with higher scores indicating better performance. Domain scores are calculated by summing the scores of the individual questions that make up the domain and multiplying the sum by the factor in the table below. The full scale score is the sum of the six domain scores.\n\nFull Scale Score range: 2.0(minimum score) - 36.0 (maximum score)\n\nNegative Score = Reduced functioning Positive Score = Improved functioning'}, {'measure': 'Change From Baseline in 36-item Short Form Health Survey (SF-36)', 'timeFrame': 'Day 85, Day 169', 'description': "The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.\n\nScores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement"}, {'measure': 'Geometric Mean of Trough Concentration (Cmin) of Abatacept', 'timeFrame': 'Day 29, 85, 113, 141, 169', 'description': 'Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.'}, {'measure': 'Percentage of Participants With a Positive Antibody Response', 'timeFrame': 'Day 85 db, day 169 db, post treatment day 85', 'description': 'Percentage of participants with at least one positive immunogenicity response up to Day 169 and during 3 months follow up (for participants who discontinue during the 6-months double-blind).'}, {'measure': 'Summary of Adverse Events: Double Blind Period', 'timeFrame': 'Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.', 'description': 'Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation'}, {'measure': 'Laboratory Marked Abnormalities: Double Blind Period', 'timeFrame': 'Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.', 'description': 'Laboratory values meeting the marked abnormality criteria'}, {'measure': 'Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period', 'timeFrame': 'Day 365, post open label treatment day 85', 'description': 'Percentage of participants with at least one positive immunogenicity response On Day 365 (end of Open label treatment period) and day 85 post open label follow up period.'}, {'measure': 'Summary of Adverse Events: Cumulative Abatacept Period', 'timeFrame': 'Day 365 and 3 months of follow up approximately 450 Days', 'description': 'Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation'}, {'measure': 'Laboratory Marked Abnormalities: Cumulative Abatacept Period', 'timeFrame': 'Day 365 and 3 months of follow up approximately 450 Days', 'description': 'Laboratory values meeting the marked abnormality criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sjogrens Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5\n* Positive anti-SS-A/Ro antibody at screening\n* meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)\n\nExclusion Criteria:\n\n* Secondary Sjögrens syndrome\n* Active life-threatening or organ-threatening complications of Sjögren's-syndrome\n* Other medical condition associated with sicca syndrome\n\nOther protocol defined inclusion/exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT02915159', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome', 'orgStudyIdInfo': {'id': 'IM101-603'}, 'secondaryIdInfos': [{'id': '2016-001948-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abatacept', 'description': 'Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months', 'interventionNames': ['Biological: Abatacept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months', 'interventionNames': ['Biological: 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