Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT02161406
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2014-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spino@umich.edu', 'phone': '734-615-5469', 'title': 'Dr. Cathie Spino', 'organization': 'University of Michigan DCC (SABER)'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'Coding of adverse events into body system was performed by the study chair for adverse events and by the medical monitors for serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 35, 'seriousNumAtRisk': 44, 'deathsNumAffected': 2, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 40, 'seriousNumAtRisk': 44, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 39, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non-serious Adverse Events', 'notes': 'Specific adverse event terms that occurred in \\< 5% of subjects were pooled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting (Emesis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritis (Itching)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cellulitis of right elbow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Healthcare associated pneumonia (HCAP)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left side mastoiditis/ abrythnitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Digital Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NSTEMI Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Arterial Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Arterial Hypertension and Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening AV block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia due to GI dysmotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia from myositis and prolonged hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosive esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GAVE; Severe anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Melena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudo obstruction of the small bowel, paralytic ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GAVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression with Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma (BCC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous Cell Carcinoma In-situ Left Anterior Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': 'Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.24', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-4.49', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 52 weeks', 'description': 'The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness. mRSS scores have a range from 0 to 51, with higher score indicating greater severity of SSc (worse outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.423', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.457', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.290', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.318', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change in % Predicted FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-4.13', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 52 weeks', 'description': 'FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson \\[Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87\\], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) \\* 100, where FVC predicted is calculated relative to a reference population.', 'unitOfMeasure': 'percent predicted', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in FVC (in ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.39', 'spread': '43.82', 'groupId': 'OG000'}, {'value': '-121.6', 'spread': '46.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'FVC = forced vital capacity, a measure of lung function', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability). Higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.42', 'spread': '5.638', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '6.045', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for disease severity ranges from 0 (no disease) to 150 (very severe). A higher score means a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9.30', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '16.95', 'spread': '5.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much breathing problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's", 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7.58', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '-3.64', 'spread': '7.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much Raynaud's interfered with daily activities ranges from 0 (does not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.18', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '8.67', 'spread': '5.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much finger ulcers interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9.98', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '8.01', 'spread': '6.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much intestinal problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Swollen Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.595', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.601', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 52 weeks', 'description': '28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome.', 'unitOfMeasure': 'number of swollen joints', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Tender Joint Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 52 weeks', 'description': '28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome.', 'unitOfMeasure': 'number of tender joints', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS-29 - Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.54', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS-29 - Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '1.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the anxiety domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS-29 - Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the depression domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS 29 - Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.65', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the fatigue domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the sleep disturbance domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e.,worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS-29 - Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.10', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.11', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the ability to participate in social roles and activities domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain intensity domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in SCTC GIT - Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.050', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The SCTC GIT is the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Instrument. It assesses scleroderma-related gastrointestinal symptoms. The composite score ranges from 0 to 2.83; 0 indicates better health and higher score indicates worse health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'ACR CRISS at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '.005', 'upperLimit': '.994'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.750'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 52', 'description': 'The American College of Rheumatology Combined Response Index in Systemic Sclerosis is a composite endpoint. It is determined in a 2-step process. The first step assesses whether the patient has had a significant decline in renal or cardiopulmonary involvement. If none of these apply, the second step assesses the probability of improvement by measuring changes in five outcomes and integrating them into a single number using an equation described in Khanna D, Berrocal VJ, et al. \\[The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis and Rheumatology. 2016; 68(2):299-311.\\]. It incorporates changes in the modified Rodnan skin score, percent predicted forced vital capacity (FVC), patient and physician global assessments, and SHAQ-DI over 1 year. The score ranges from 0 to 1; a higher score indicates better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS - Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.44', 'spread': '1.209', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '1.285', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1769', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure fatigue domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS - Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.573', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.620', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9075', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 4-question short-form health-reported quality of life measure sleep disturbance domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in PROMIS - Sleep Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '1.267', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '1.320', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5831', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure sleep impairment domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.119', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0193', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Hygiene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.125', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0097', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Arising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.109', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0751', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Reach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.176', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.127', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4927', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.122', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1604', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Grip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.149', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7281', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Walking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.106', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1679', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.121', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2906', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population includes all of the randomized participants who received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'investigator withdrew subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension\n\nAbatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': '125mg Placebo\n\nPlacebo: 125 mg of Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '12', 'groupId': 'BG000'}, {'value': '49', 'spread': '13', 'groupId': 'BG001'}, {'value': '49', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease Duration', 'classes': [{'categories': [{'measurements': [{'value': '1.66', 'spread': '0.84', 'groupId': 'BG000'}, {'value': '1.52', 'spread': '0.79', 'groupId': 'BG001'}, {'value': '1.59', 'spread': '0.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Disease duration for this outcome is defined as the disease duration since the first non-Raynaud's sign or symptom until the screening visit.", 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'dcSSc Disease Duration <= 18 months', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'dcSSc disease duration is defined as the time from the diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) until screening.', 'unitOfMeasure': 'Participants'}, {'title': 'mRSS', 'classes': [{'categories': [{'measurements': [{'value': '23.34', 'spread': '7.947', 'groupId': 'BG000'}, {'value': '21.57', 'spread': '7.328', 'groupId': 'BG001'}, {'value': '22.45', 'spread': '7.652', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'modified Rodnan skin scores (mRSS) have a range from 0 to 51, with higher score indicating greater severity of systemic scleroderma', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FVC% Predicted', 'classes': [{'categories': [{'measurements': [{'value': '84.19', 'spread': '13.504', 'groupId': 'BG000'}, {'value': '86.49', 'spread': '16.597', 'groupId': 'BG001'}, {'value': '85.34', 'spread': '15.087', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson \\[Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87\\], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) \\* 100, where FVC predicted is calculated relative to a reference population.', 'unitOfMeasure': 'percent predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'DLCO% Predicted, Corrected for Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '79.57', 'spread': '18.117', 'groupId': 'BG000'}, {'value': '76.45', 'spread': '18.439', 'groupId': 'BG001'}, {'value': '78.01', 'spread': '18.241', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Percent predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin (Hb), is reported. For adult males, the equation (expressing Hb in gm•dL-1) is DLCO predicted × (1.7\\*Hb / (10.22+Hb)). In adult women, the equation is DLCO predicted × (1.7\\*Hb / (9.38+Hb)). Percent predicted DLCO was entered directly into the eCRFs, based on equipment and testing techniques meeting ATS/ERS requirements (Crapo RO, Morris AH. Standardized single breath normal values for carbon monoxide diffusing capacity. Am.Rev.Respir.Dis 1981;123:185-189).', 'unitOfMeasure': 'percent predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Global Assessment', 'classes': [{'categories': [{'measurements': [{'value': '3.88', 'spread': '2.206', 'groupId': 'BG000'}, {'value': '4.31', 'spread': '2.561', 'groupId': 'BG001'}, {'value': '4.09', 'spread': '2.384', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HAQ-DI', 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '0.716', 'groupId': 'BG000'}, {'value': '0.97', 'spread': '0.701', 'groupId': 'BG001'}, {'value': '1.05', 'spread': '0.710', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physician Global Assessment', 'classes': [{'categories': [{'measurements': [{'value': '4.77', 'spread': '1.669', 'groupId': 'BG000'}, {'value': '4.76', 'spread': '1.665', 'groupId': 'BG001'}, {'value': '4.77', 'spread': '1.657', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Physician global assessment for overall disease: This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Proportion of Participants with >= 1 Tendon Friction Rubs', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Tendon friction rubs in systemic sclerosis have been associated with diffuse cutaneous skin disease, increased disability and poor survival. They were considered present if palpable on physical exam in the shoulder, elbow, wrist, metacarpophalangeal (MCP) joint, knee, and ankle. We report the proportion of subjects with at least one tendon friction rub.', 'unitOfMeasure': 'Participants'}, {'title': 'Proportion of Participants with >= 1 Large Joint Contractures', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Joint contractures are recognized by the loss of joint motion upon physical exam. We report the proportion of subjects with at least one large joint contracture.', 'unitOfMeasure': 'Participants'}, {'title': 'Swollen Joint Count', 'classes': [{'categories': [{'measurements': [{'value': '3.64', 'spread': '5.620', 'groupId': 'BG000'}, {'value': '3.86', 'spread': '5.849', 'groupId': 'BG001'}, {'value': '3.75', 'spread': '5.704', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28.', 'unitOfMeasure': 'number of swollen joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Proportion of Participants with >= 1 Swollen Joint Count', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. We report the proportion of participants with \\>= 1 swollen joint.', 'unitOfMeasure': 'Participants'}, {'title': 'Proportion of Participants with Previous Use of Immunosuppressives', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Proportion of Participants with Previous Use of Prednisone', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population includes all of the randomized participants who received at least one dose of study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-08', 'size': 1147310, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-02T19:35', 'hasProtocol': True}, {'date': '2018-04-06', 'size': 1320156, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-02T19:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2014-06-03', 'resultsFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2014-06-09', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-28', 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year', 'timeFrame': '52 weeks', 'description': 'Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs'}, {'measure': 'Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12', 'timeFrame': 'Baseline and 52 weeks', 'description': 'The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness. mRSS scores have a range from 0 to 51, with higher score indicating greater severity of SSc (worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease', 'timeFrame': 'Baseline and Week 52', 'description': "Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease', 'timeFrame': 'Baseline and Week 52', 'description': "This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome."}, {'measure': 'Change in % Predicted FVC', 'timeFrame': 'Baseline and 52 weeks', 'description': 'FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson \\[Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87\\], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) \\* 100, where FVC predicted is calculated relative to a reference population.'}, {'measure': 'Change From Baseline to Month 12 in FVC (in ml)', 'timeFrame': 'Baseline and Week 52', 'description': 'FVC = forced vital capacity, a measure of lung function'}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Overall', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability). Higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for disease severity ranges from 0 (no disease) to 150 (very severe). A higher score means a worse outcome."}, {'measure': 'Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much breathing problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome."}, {'measure': "Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's", 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much Raynaud's interfered with daily activities ranges from 0 (does not limit activities) to 150 (very severe limitation). A higher score means a worse outcome."}, {'measure': 'Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much finger ulcers interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome."}, {'measure': 'Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement', 'timeFrame': 'Baseline and Week 52', 'description': "Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much intestinal problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome."}, {'measure': 'Change From Baseline to Month 12 in Swollen Joint Count', 'timeFrame': 'Baseline and 52 weeks', 'description': '28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome.'}, {'measure': 'Change From Baseline to Month 12 in Tender Joint Counts', 'timeFrame': 'Baseline and 52 weeks', 'description': '28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome.'}, {'measure': 'Change From Baseline to Month 12 in PROMIS-29 - Physical Function', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS-29 - Anxiety', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the anxiety domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS-29 - Depression', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the depression domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS 29 - Fatigue', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the fatigue domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the sleep disturbance domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e.,worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS-29 - Pain Interference', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the ability to participate in social roles and activities domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain intensity domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in SCTC GIT - Composite Score', 'timeFrame': 'Baseline and Week 52', 'description': 'The SCTC GIT is the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Instrument. It assesses scleroderma-related gastrointestinal symptoms. The composite score ranges from 0 to 2.83; 0 indicates better health and higher score indicates worse health.'}, {'measure': 'ACR CRISS at 12 Months', 'timeFrame': 'Week 52', 'description': 'The American College of Rheumatology Combined Response Index in Systemic Sclerosis is a composite endpoint. It is determined in a 2-step process. The first step assesses whether the patient has had a significant decline in renal or cardiopulmonary involvement. If none of these apply, the second step assesses the probability of improvement by measuring changes in five outcomes and integrating them into a single number using an equation described in Khanna D, Berrocal VJ, et al. \\[The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis and Rheumatology. 2016; 68(2):299-311.\\]. It incorporates changes in the modified Rodnan skin score, percent predicted forced vital capacity (FVC), patient and physician global assessments, and SHAQ-DI over 1 year. The score ranges from 0 to 1; a higher score indicates better outcome.'}, {'measure': 'Change From Baseline to Month 12 in PROMIS - Fatigue', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure fatigue domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS - Sleep Disturbance', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 4-question short-form health-reported quality of life measure sleep disturbance domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).'}, {'measure': 'Change From Baseline to Month 12 in PROMIS - Sleep Impairment', 'timeFrame': 'Baseline and Week 52', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure sleep impairment domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).'}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Hygiene', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Arising', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Reach', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Eating', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Grip', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Walking', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}, {'measure': 'Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities', 'timeFrame': 'Baseline and Week 52', 'description': "The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scleroderma'], 'conditions': ['Diffuse Cutaneous Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '36355434', 'type': 'DERIVED', 'citation': 'Mehta BK, Espinoza ME, Franks JM, Yuan Y, Wang Y, Wood T, Gudjonsson JE, Spino C, Fox DA, Khanna D, Whitfield ML. Machine-learning classification identifies patients with early systemic sclerosis as abatacept responders via CD28 pathway modulation. JCI Insight. 2022 Dec 22;7(24):e155282. doi: 10.1172/jci.insight.155282.'}, {'pmid': '34966900', 'type': 'DERIVED', 'citation': 'Chung L, Spino C, McLain R, Johnson SR, Denton CP, Molitor JA, Steen VD, Lafyatis R, Simms RW, Kafaja S, Frech TM, Hsu V, Domsic RT, Pope JE, Gordon JK, Mayes MD, Sandorfi N, Hant FN, Bernstein EJ, Chatterjee S, Castelino FV, Ajam A, Allanore Y, Matucci-Cerinic M, Whitfield ML, Distler O, Singer O, Young A, Nagaraja V, Fox DA, Furst DE, Khanna D. Safety and efficacy of abatacept in early diffuse cutaneous systemic sclerosis (ASSET): open-label extension of a phase 2, double-blind randomised trial. Lancet Rheumatol. 2020 Dec;2(12):e743-e753. doi: 10.1016/S2665-9913(20)30237-X. Epub 2020 Oct 19.'}, {'pmid': '31342624', 'type': 'DERIVED', 'citation': 'Khanna D, Spino C, Johnson S, Chung L, Whitfield ML, Denton CP, Berrocal V, Franks J, Mehta B, Molitor J, Steen VD, Lafyatis R, Simms RW, Gill A, Kafaja S, Frech TM, Hsu V, Domsic RT, Pope JE, Gordon JK, Mayes MD, Schiopu E, Young A, Sandorfi N, Park J, Hant FN, Bernstein EJ, Chatterjee S, Castelino FV, Ajam A, Wang Y, Wood T, Allanore Y, Matucci-Cerinic M, Distler O, Singer O, Bush E, Fox DA, Furst DE. Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator-Initiated, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):125-136. doi: 10.1002/art.41055. Epub 2019 Dec 10.'}], 'seeAlsoLinks': [{'url': 'http://www.med.umich.edu/scleroderma', 'label': 'To learn more about the Scleroderma program at the University of Michigan'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score \\[mRSS\\]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.', 'detailedDescription': 'This study is a randomized placebo-controlled double-blind phase 2 trial of patients with dcSSc. Eligible participants will be randomized in a 1:1 ratio to either 125 mg SC abatacept or matching placebo, stratified by duration of dcSSc disease duration (\\<18 months vs \\>18 to \\</=36 months). Study participants will be treated for 12 months on double-blind study medication, followed by an additional 24 weeks of open-label SC abatacept therapy. 86 patients will be randomized in approximately 35 centers in the US, Canada and Europe, with the goal of analyzing 74 participants. The investigators study will test whether abatacept is statistically superior to placebo in reducing the MRSS at month 12 and explore the ability of abatacept to prevent or reverse progression in patients with early disease duration and lower MRSS scores, and reverse established disease in patients with longer disease duration and higher MRSS scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc\n2. Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger\n3. Disease duration of ≤ 36 months (defined as time from the first non-Raynaud phenomenon manifestation)\n4. For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit\n5. For disease duration of \\>18-36 months: ≥ 15 and ≤ 45 mRSS units at the screening visit and one of the following:\n\n * Increase ≥ 3 in mRSS units compared with the last visit within previous 1-6 months\n * Involvement of one new body area with ≥ 2 mRSS units compared with the last visit within the previous 1-6 months\n * Involvement of two new body areas with ≥ 1 mRSS units compared with the last visit within the previous 1-6 months\n * Presence of 1 or more Tendon Friction Rub\n6. Age ≥ 18 years at the screening visit\n7. If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits\n8. Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for\n\n * 2 weeks prior to and including the baseline visit.\n9. ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for ≥ 2 weeks prior to and including the baseline visit.\n\nExclusion Criteria:\n\n1. Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy\n2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit\n3. Major surgery (including joint surgery) within 8 weeks prior to screening visit\n4. Infected ulcer prior to randomization\n5. Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit\n6. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA\n7. Anti-CD20, and cyclophosphamide within 12 months prior to baseline visit.\n8. Use of Intravenous Immunoglobulin (IVIG) within 12 weeks prior to baseline visit\n9. Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation\n10. Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to the baseline visit\n11. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, or D-penicillamine, within≤ 4 weeks prior to the baseline visit\n12. Treatment with etanercept within ≤ 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within ≤ 8 weeks, anakinra within ≤ 1 week prior to the baseline visit\n13. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin ) ≤ 40% of predicted at the screening visit\n14. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud's and digital ulcers.\n15. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).\n16. Positive for hepatitis B surface antigen prior to the baseline visit\n17. Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit\n18. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).\n19. Any of the following at the screening visit: Hemoglobin \\<8.5 g/dL; WBC \\< 3,000/mm3 (\\<3 x 109/L); platelets \\< 100,000/mm3 (\\<3 x 109/L); serum creatinine \\> 2 x ULN; serum ALT or AST \\> 2 x ULN\n20. Severe skin thickening (mRSS 3) on the inner aspects of thighs, upper arms, or abdomen\n21. Patients with a history of anaphylaxis to abatacept"}, 'identificationModule': {'nctId': 'NCT02161406', 'acronym': 'ASSET', 'briefTitle': 'A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IM101-344'}, 'secondaryIdInfos': [{'id': '1UM1AI110557', 'link': 'https://reporter.nih.gov/quickSearch/1UM1AI110557', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept', 'description': '125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension', 'interventionNames': ['Drug: Abatacept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '125mg Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia'], 'description': 'Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks', 'armGroupLabels': ['Abatacept']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '125 mg of Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Arthritis Associates of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California- Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Mass General', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08831', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University Clinical Research Center', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '12203', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Steffens Scleroderma Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'NorthWell Health', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Health Services', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'N6A4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'St. Joseph Health Care London', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Dinesh Khanna, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dinesh Khanna, MD, MS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Rheumatology/ Internal Medicine', 'investigatorFullName': 'Dinesh Khanna, MD, MS', 'investigatorAffiliation': 'University of Michigan'}}}}