Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT04511702
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2020-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031545', 'term': 'Pegloticase'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 1 year.', 'description': 'A 4-week MTX run-in period (15 mg weekly) was conducted to identify screening failures due to MTX intolerance. Of 215 participants receiving MTX, 24 discontinued before receiving pegloticase and were deemed screen failures. The remaining 191 participants completed the run-in period, received pegloticase on Day 1, and were considered enrolled in the trial. All enrolled participants received the first pegloticase dose on Day 1, followed by additional doses Q2W for a total of 22 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'MTX Run-In', 'description': 'MTX Run-In Period', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 79, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 86, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 46, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Scrotal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shigella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG001', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG002', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '12.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '24.7'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '23.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 24', 'description': "IRs, including anaphylaxis, were assessed after each infusion for a period of 24 weeks. IRs were defined as any infusion-related adverse event (AE) or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and up to 2 hours post-infusion. Additional AEs occurring outside of the 2-hour window following infusion could also be categorized as an IR at the Principal Investigator's discretion.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS): All participants who received at least 1 dose of pegloticase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Serum Uric Acid (sUA) Responders at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG001', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG002', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '57.9', 'upperLimit': '75.7'}, {'value': '76.9', 'groupId': 'OG001', 'lowerLimit': '46.2', 'upperLimit': '95.0'}, {'value': '56.5', 'groupId': 'OG002', 'lowerLimit': '43.3', 'upperLimit': '69.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'Responders were defined as participants who achieved and maintained sUA levels below 6 mg/dL for at least 80% of the time during month 6.\n\nResponders who met sUA discontinuation criteria (2 consecutive sUA \\> 6 mg/dL), regardless of treatment status were considered non-responders.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: All participants who received at least 1 dose of pegloticase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced an IR Leading to Discontinuation of Treatment, Anaphylaxis or Met sUA Discontinuation Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG001', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG002', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '27.3'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '36.0'}, {'value': '32.3', 'groupId': 'OG002', 'lowerLimit': '20.9', 'upperLimit': '45.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 24', 'description': "IRs were defined as any infusion-related AE or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and for 2 hours post-infusion. Other AEs that occurred outside of the 2 hour window following the infusion may have also been categorized as an IR at the Principal Investigator's discretion.\n\nAnaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.\n\nMeeting individual sUA discontinuation criteria was defined as two consecutive pre-infusion sUAs \\> 6 mg/dL after Day 1.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of pegloticase.'}, {'type': 'SECONDARY', 'title': 'Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG001', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG002', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median time (95% CI) to occurrence of this composite event was not estimable using Kaplan-Meier analysis due to the low number of these events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median time (95% CI) to occurrence of this composite event was not estimable using Kaplan-Meier analysis due to the low number of these events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median time (95% CI) to occurrence of this composite event was not estimable using Kaplan-Meier analysis due to the low number of these events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Week 24', 'description': "Infusion reactions were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion.\n\nAnaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.\n\nMeeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1.\n\nTime to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. All participants were censored at the date of their last infusion.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: All participants who received at least 1 dose of pegloticase.'}, {'type': 'SECONDARY', 'title': 'Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG001', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'OG002', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '113'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '15'}, {'value': '43.0', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '144'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Week 24', 'description': "IRs were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion.\n\nAnaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.\n\nMeeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1.\n\nTime to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. Only participants who experienced an event were included in this analysis.", 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of pegloticase and experienced an IR leading to discontinuation of treatment, anaphylaxis or met sUA discontinuation criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'FG001', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'FG002', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants with uncontrolled gout were enrolled at 36 centers across the United States between October 2020 and March 2024.', 'preAssignmentDetails': 'A 4-week methotrexate (MTX) run-in period, with a weekly dose of 15 mg, was used to identify screening failures due to MTX intolerance. All participants who completed the run-in period received their first dose of pegloticase on Day 1, followed by additional doses every 2 weeks (Q2W) for a total of 22 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegloticase 60 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'BG001', 'title': 'Pegloticase 45 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'BG002', 'title': 'Pegloticase 30 Minute + MTX', 'description': 'Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '11.33', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '9.96', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '11.04', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '11.20', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}, {'title': 'More than 1 race', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intent-to-treat (mITT) Analysis Set: All participants who received at least 1 dose of pegloticase.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-09', 'size': 1434079, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-12T21:50', 'hasProtocol': True}, {'date': '2024-01-19', 'size': 4791081, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-12T21:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Three different infusion durations may be used. 60-minute infusion, 45-minute infusion and 30-minute.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2020-08-11', 'resultsFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-12-12', 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24', 'timeFrame': 'Day 1 to Week 24', 'description': "IRs, including anaphylaxis, were assessed after each infusion for a period of 24 weeks. IRs were defined as any infusion-related adverse event (AE) or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and up to 2 hours post-infusion. Additional AEs occurring outside of the 2-hour window following infusion could also be categorized as an IR at the Principal Investigator's discretion."}], 'secondaryOutcomes': [{'measure': 'Percentage of Serum Uric Acid (sUA) Responders at Month 6', 'timeFrame': 'Up to 6 months', 'description': 'Responders were defined as participants who achieved and maintained sUA levels below 6 mg/dL for at least 80% of the time during month 6.\n\nResponders who met sUA discontinuation criteria (2 consecutive sUA \\> 6 mg/dL), regardless of treatment status were considered non-responders.'}, {'measure': 'Percentage of Participants Who Experienced an IR Leading to Discontinuation of Treatment, Anaphylaxis or Met sUA Discontinuation Criteria', 'timeFrame': 'Day 1 to Week 24', 'description': "IRs were defined as any infusion-related AE or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and for 2 hours post-infusion. Other AEs that occurred outside of the 2 hour window following the infusion may have also been categorized as an IR at the Principal Investigator's discretion.\n\nAnaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.\n\nMeeting individual sUA discontinuation criteria was defined as two consecutive pre-infusion sUAs \\> 6 mg/dL after Day 1."}, {'measure': 'Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in All Participants', 'timeFrame': 'Day 1 to Week 24', 'description': "Infusion reactions were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion.\n\nAnaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.\n\nMeeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1.\n\nTime to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. All participants were censored at the date of their last infusion."}, {'measure': 'Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in Participants With an Event', 'timeFrame': 'Day 1 to Week 24', 'description': "IRs were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion.\n\nAnaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.\n\nMeeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1.\n\nTime to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. Only participants who experienced an event were included in this analysis."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gout', 'uncontrolled gout'], 'conditions': ['Chronic Uncontrolled Gout', 'Gout', 'Uncontrolled Gout']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.', 'detailedDescription': 'Approximately 180 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-minute infusion, 45-minute infusion and 30-minute infusion. Safety evaluations will be performed regularly throughout the course of the study.\n\nAcquired from Horizon in 2024.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult men or women ≥18 years of age.\n2. Uncontrolled gout, defined as meeting the following criteria:\n\n * Hyperuricemia during the screening period defined as sUA ≥6 mg/dL\n * Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with intolerable side effects or a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview.\n * Symptoms of gout including at least 1 of the following:\n\n * Presence of at least one tophus\n * Recurrent flares defined as 2 or more flares in the past 12 months prior to screening\n * Presence of chronic gouty arthritis\n3. Willing to discontinue all oral urate-lowering therapy at least 7 days prior to MTX dosing at Week -4 and remain off of urate lowering therapy when receiving pegloticase infusions during the study.\n\nExclusion Criteria:\n\n1. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.\n2. Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (defined as 3 months or longer) would also meet exclusion criteria.\n3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit).\n4. Severe chronic renal impairment (estimated glomerular filtration rate \\<40 mL/min/1.73 m2) at the Screening Visit based on 4 variable-Modification of Diet in Renal Disease \\[MDRD\\] formula or currently on dialysis.\n5. Non-compensated congestive heart failure or hospitalization for congestive heart failure or treatment for acute coronary syndrome (myocardial infarction or unstable angina) within 3 months of the Screening Visit, or current uncontrolled arrhythmia, or current uncontrolled blood pressure (BP) (\\>160/100 mmHg) prior to Week -4.\n6. Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner, or not on an effective form of birth control, as determined by the Investigator.\n7. Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug.\n8. Currently receiving systemic or radiologic treatment for ongoing cancer.\n9. History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix.'}, 'identificationModule': {'nctId': 'NCT04511702', 'briefTitle': 'Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate', 'orgStudyIdInfo': {'id': 'HZNP-KRY-403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegloticase 60 Minute Infusion with methotrexate (MTX)', 'description': 'Pegloticase 60 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks', 'interventionNames': ['Biological: Pegloticase with MTX']}, {'type': 'EXPERIMENTAL', 'label': 'Pegloticase 45 Minute Infusion with methotrexate (MTX)', 'description': 'Pegloticase 45 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks', 'interventionNames': ['Biological: Pegloticase with MTX']}, {'type': 'EXPERIMENTAL', 'label': 'Pegloticase 30 Minute Infusion with methotrexate (MTX)', 'description': 'Pegloticase 30 Minute Infusion with methotrexate (MTX). 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