Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-03 @ 6:50 AM
Study NCT ID:
NCT01863732
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension in AS: Sustainability of Benefits, Safety and Tolerability
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '8627788300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1', 'description': 'Safety includes cumulative data for core \\& extension for patients who continued in the extension.', 'eventGroups': [{'id': 'EG000', 'title': 'Any Secukinumab (AIN457) 75 mg', 'description': 'Any Secukinumab (AIN457) 75 mg safety in Core Study CAIN457F2305 and this extension study.', 'otherNumAtRisk': 179, 'deathsNumAtRisk': 179, 'otherNumAffected': 126, 'seriousNumAtRisk': 179, 'deathsNumAffected': 2, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Any Secukinumab (AIN457) 150 mg', 'description': 'Any Secukinumab (AIN457) 150 mgsafety in Core Study CAIN457F2305 and this extension study', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 157, 'seriousNumAtRisk': 263, 'deathsNumAffected': 1, 'seriousNumAffected': 33}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo in Core study CAIN457F2305E1', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 45, 'seriousNumAtRisk': 122, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ankylosing spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Abdominal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Lumbar hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 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Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.'}, {'id': 'OG003', 'title': 'Pbo in Core Then AIN457 150mg Group 2', 'description': 'Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.'}], 'classes': [{'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '78.6', 'groupId': 'OG002'}, {'value': '73.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.0', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}, {'value': '76.1', 'groupId': 'OG002'}, {'value': '70.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 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'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}, {'value': '84.8', 'groupId': 'OG001'}, {'value': '81.0', 'groupId': 'OG002'}, {'value': '73.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}, {'value': '79.7', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '78.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 220', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': 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Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.'}, {'id': 'OG001', 'title': 'Secukinumab (AIN457) 150mg Group 2', 'description': 'AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.'}, {'id': 'OG002', 'title': 'Pbo in Core Then AIN457 75mg Group 1', 'description': 'Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.'}, {'id': 'OG003', 'title': 'Pbo in Core Then AIN457 150mg Group 2', 'description': 'Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.'}], 'classes': [{'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}, {'value': '48.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '59.5', 'groupId': 'OG001'}, {'value': '54.3', 'groupId': 'OG002'}, {'value': '51.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 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'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}, {'value': '52.4', 'groupId': 'OG002'}, {'value': '62.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000'}, {'value': '60.8', 'groupId': 'OG001'}, {'value': '62.5', 'groupId': 'OG002'}, {'value': '56.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 220', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': 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In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260', 'timeFrame': 'Week 104 to Week 260', 'description': 'ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, secukinumab, self-injection'], 'conditions': ['Spondylitis, Ankylosing']}, 'referencesModule': {'references': [{'pmid': '33351179', 'type': 'DERIVED', 'citation': 'Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.'}, {'pmid': '33324394', 'type': 'DERIVED', 'citation': 'Tseng JC, Wei JC, Deodhar A, Martin R, Porter B, McCreddin S, Talloczy Z. Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1. Front Immunol. 2020 Nov 26;11:561748. doi: 10.3389/fimmu.2020.561748. eCollection 2020.'}, {'pmid': '33227175', 'type': 'DERIVED', 'citation': 'Kvien TK, Conaghan PG, Gossec L, Strand V, Ostergaard M, Poddubnyy D, Williams N, Porter B, Shete A, Gilloteau I, Deodhar A. Secukinumab and Sustained Reduction in Fatigue in Patients With Ankylosing Spondylitis: Long-Term Results of Two Phase III Randomized Controlled Trials. Arthritis Care Res (Hoboken). 2022 May;74(5):759-767. doi: 10.1002/acr.24517. Epub 2022 Mar 10.'}, {'pmid': '31565244', 'type': 'DERIVED', 'citation': 'Baraliakos X, Braun J, Deodhar A, Poddubnyy D, Kivitz A, Tahir H, Van den Bosch F, Delicha EM, Talloczy Z, Fierlinger A. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019 Sep 3;5(2):e001005. doi: 10.1136/rmdopen-2019-001005. eCollection 2019.'}, {'pmid': '30590813', 'type': 'DERIVED', 'citation': 'Braun J, Baraliakos X, Deodhar A, Poddubnyy D, Emery P, Delicha EM, Talloczy Z, Porter B. Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study. Rheumatology (Oxford). 2019 May 1;58(5):859-868. doi: 10.1093/rheumatology/key375.'}], 'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com', 'label': 'Introduction to clinical research conducted by Novartis and to the results of completed studies. 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