Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01844518
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2013-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 113 months). SAEs and Other AEs were assessed from first dose to 168 days after last dose of study therapy (assessed up to approximately 113 months).', 'description': 'Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 127, 'seriousNumAtRisk': 173, 'deathsNumAffected': 0, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'SC Abatacept Ages 2 to 5', 'description': 'SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \\< 25 kg (50 mg in 0.4 mL PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 44, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Scarlet fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Complicated appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Joint hyperextension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Ovarian germ cell teratoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 113', 'description': 'Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be \\>= 10 µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with available PK measurements. Endpoint pre-specified to only be collected for 6-17 year age group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}], 'classes': [{'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000', 'lowerLimit': '77.7', 'upperLimit': '88.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 113', 'description': "ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables:\n\n1. number of active joints\n2. number of joints with limitation of motion (LOM)\n3. physician global assessment of disease activity\n4. parent global assessment of patient overall well-being\n5. functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ)\n6. C-reactive protein (CRP). In addition to the above condition, to be considered a responder participants cannot have ≥30% worsening in more than 1 of the 3 remaining JIA core set variables for which improvement was not observed.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the 6-17 Year Age-Group Cohort. Endpoint prespecified to only be collected for 6-17 year age group.'}, {'type': 'SECONDARY', 'title': 'Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 to <25 kg Dosing Group', 'description': 'Weight-tiered dosing group received 50 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly.'}, {'id': 'OG001', 'title': '25 to <50 kg Dosing Group', 'description': 'Weight-tiered dosing group received 87.5 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly.'}, {'id': 'OG002', 'title': '>=50 kg Dosing Group', 'description': 'Weight-tiered dosing group received 125 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly'}], 'classes': [{'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '32', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '35', 'groupId': 'OG001'}, {'value': '33.0', 'spread': '33', 'groupId': 'OG002'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.7', 'spread': '38', 'groupId': 'OG000'}, {'value': '42.5', 'spread': '32', 'groupId': 'OG001'}, {'value': '36.0', 'spread': '40', 'groupId': 'OG002'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.3', 'spread': '39', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '34', 'groupId': 'OG001'}, {'value': '36.6', 'spread': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 57, 85 and 113', 'description': "Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL). Here 'n' number analyzed signifies participants who were evaluable for each time point.", 'unitOfMeasure': 'microgram per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with available PK measurements in the 6-17 Year Age-Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Drug-Related SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Overall AEs', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'Drug-Related AEs', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period)', 'description': 'An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the short-term period in the 6-17 Year Age Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}, {'id': 'OG001', 'title': 'SC Abatacept Ages 2 to 5', 'description': 'SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \\< 25 kg (50 mg in 0.4 mL PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuation Due to SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall AEs', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-Related AEs', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuation Due to AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 56 days after last dose ( up to approximately 2 years)', 'description': 'An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the cumulative period'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term)', 'description': "Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the short term (ST) period (initial 4-month treatment period) or completed the ST study without continuing abatacept treatment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the short-term period with available immunogenicity measurements in the 6-17 Year Age-Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Immunogenicity Response in the Cumulative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}, {'id': 'OG001', 'title': 'SC Abatacept Ages 2 to 5', 'description': 'SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \\< 25 kg (50 mg in 0.4 mL PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 6 months following treatment discontinuation (up to approximately 2 years)', 'description': "Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the short term (ST) or long term (LT) period, elected not to enter the LT period, or completed both ST and LT periods.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in the cumulative period with available immunogenicity measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}, {'id': 'FG001', 'title': 'SC Abatacept Ages 2 to 5', 'description': 'SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \\< 25 kg (50 mg in 0.4 mL PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': "Participant's request to discontinue", 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No Longer Met Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '219 participants were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SC Abatacept Ages 6 to 17', 'description': 'Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\\<) 25 kilogram (kg) (50 milligram \\[mg\\] in 0.4 milliliter \\[mL\\] PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}, {'id': 'BG001', 'title': 'SC Abatacept Ages 2 to 5', 'description': 'SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \\< 25 kg (50 mg in 0.4 mL PFS), 25 to \\< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Race', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'title': '<25 kg', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '25 to 50 kg', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': '>=50 kg', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated population included all participants who received at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-26', 'studyFirstSubmitDate': '2013-04-29', 'resultsFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-23', 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17', 'timeFrame': 'Day 113', 'description': 'Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be \\>= 10 µg/mL.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)', 'timeFrame': 'Day 113', 'description': "ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables:\n\n1. number of active joints\n2. number of joints with limitation of motion (LOM)\n3. physician global assessment of disease activity\n4. parent global assessment of patient overall well-being\n5. functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ)\n6. C-reactive protein (CRP). In addition to the above condition, to be considered a responder participants cannot have ≥30% worsening in more than 1 of the 3 remaining JIA core set variables for which improvement was not observed."}, {'measure': 'Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose', 'timeFrame': 'Days 57, 85 and 113', 'description': "Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL). Here 'n' number analyzed signifies participants who were evaluable for each time point."}, {'measure': 'Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort', 'timeFrame': 'From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period)', 'description': 'An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period', 'timeFrame': 'From first dose up to 56 days after last dose ( up to approximately 2 years)', 'description': 'An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort', 'timeFrame': 'From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term)', 'description': "Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the short term (ST) period (initial 4-month treatment period) or completed the ST study without continuing abatacept treatment."}, {'measure': 'Number of Participants With Positive Immunogenicity Response in the Cumulative Period', 'timeFrame': 'From first dose up to 6 months following treatment discontinuation (up to approximately 2 years)', 'description': "Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the short term (ST) or long term (LT) period, elected not to enter the LT period, or completed both ST and LT periods."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Active Polyarticular Juvenile Idiopathic Arthritis']}, 'referencesModule': {'references': [{'pmid': '37453737', 'type': 'DERIVED', 'citation': 'Ruperto N, Lovell DJ, Berman A, Anton J, Viola DO, Lauwerys B, Rama ME, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Ally M, Rubio-Perez N, Gervais E, Van Zyl R, Wong R, Askelson M, Martini A, Brunner HI; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials. J Rheumatol. 2023 Nov;50(11):1471-1480. doi: 10.3899/jrheum.2022-1320. Epub 2023 Jul 15.'}, {'pmid': '37221146', 'type': 'DERIVED', 'citation': 'Brunner HI, Tzaribachev N, Louw I, Calvo Penades I, Avila-Zapata F, Horneff G, Foeldvari I, Kingsbury DJ, Paz Gastanaga ME, Wouters C, Breedt J, Wong R, Askelson M, Zhuo J, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG) investigators. Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2259-2266. doi: 10.1002/acr.25156. Epub 2023 Jun 22.'}, {'pmid': '36710243', 'type': 'DERIVED', 'citation': 'Ruperto N, Lovell DJ, Berman A, Avila-Zapata F, Horneff G, Alessio M, Becker ML, Belot A, Burgos-Vargas R, Gamir ML, Goldenstein-Schainberg C, Scheibel IM, Terreri MT, Zemel L, Zhuo J, Askelson M, Wong R, Martini A, Brunner HI; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1804-1814. doi: 10.1002/acr.24989. Epub 2023 Jan 29.'}, {'pmid': '33452173', 'type': 'DERIVED', 'citation': 'Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.'}, {'pmid': '32087715', 'type': 'DERIVED', 'citation': 'Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penades I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept. Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.'}, {'pmid': '29481737', 'type': 'DERIVED', 'citation': 'Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Berman A, Calvo Penades I, Anton J, Avila-Zapata F, Cuttica R, Horneff G, Foeldvari I, Keltsev V, Kingsbury DJ, Viola DO, Joos R, Lauwerys B, Paz Gastanaga ME, Rama ME, Wouters C, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Miraval T, Ally MMTM, Rubio-Perez N, Solau Gervais E, van Zyl R, Li X, Nys M, Wong R, Banerjee S, Lovell DJ, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). 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