Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 3:06 AM
Study NCT ID:
NCT01466166
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2011-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031545', 'term': 'Pegloticase'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@horizonpharma.com', 'phone': '224-383-3000', 'title': 'Jeffery Nieves, PharmD', 'organization': 'Horizon Pharma Rheumatology LLC'}, 'certainAgreement': {'otherDetails': 'Horizon requests that any investigator/institution that plans on presenting/publishing results provide written notification of their request 60 days prior to their presentation/publication. Horizon requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Horizon needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug to the end of the 12-week follow-up period (63 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 130, 'seriousNumAtRisk': 188, 'deathsNumAffected': 3, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 11}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 126}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastrointestinal arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Infusion Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': 'Infusion reactions were defined as adverse events (AEs) or clusters of events, not attributable to another cause that occurred during or within 2 hours after the infusion of pegloticase. Any other case that occurred outside of the 2-hour window was categorized per Investigator discretion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population included all enrolled participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anaphylaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': "Anaphylaxis was defined using the National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network (NIAID/FAAN) criteria: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives; pruritus or flushing; swollen lips, tongue, or uvula), and at least 1 of the following:\n\n1. Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia).\n2. Reduced blood pressure (i.e., systolic blood pressure \\< 90 mm Hg or greater than 30% decrease from that patient's baseline) or associated symptoms of end-organ failure (e.g., hypotonia \\[collapse\\], syncope, incontinence).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Immune Complex-related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to the end of the 12-week follow-up period (63 weeks).', 'description': 'Immune complex-related events were defined as any presumptive immune complex-related disorders that were confirmed by an appropriate investigation of the event and of complement markers (C3 and C4 levels). Clinical manifestations could have included skin rash, arthralgia, arthritis, proteinuria, serum sickness, and cryoglobulinemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Normalization of Serum Uric Acid at Week 24 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and week 52', 'description': 'Normalization of serum uric acid was defined as serum uric acid value less than 6 mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with missing values at week 24 or 52 are counted as not achieving normalization'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Gout Flares', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24 and week 48', 'description': 'The number of gout flares occurring in the 2 weeks prior to each visit. Baseline number of flares was calculated as the average number of flares that occurred in the 6-month baseline period divided by 12 weeks.', 'unitOfMeasure': 'flares', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with a value at baseline and each time point'}, {'type': 'SECONDARY', 'title': 'Number of Swollen Joints Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.60', 'spread': '10.847', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.05', 'spread': '7.241', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.46', 'spread': '3.336', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 24 and 52', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Tender Joints Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.33', 'spread': '11.715', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '5.539', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.318', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 24 and 52', 'unitOfMeasure': 'tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Palpable Tophi Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.58', 'spread': '18.999', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.70', 'spread': '5.643', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.68', 'spread': '3.038', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 24 and 52', 'description': 'Gout tophi are nodular deposits of urate crystals and inflammatory cells in joints, soft tissues, bones, and in some organs.', 'unitOfMeasure': 'tophi', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at baseline and each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}]}, {'type': 'Completed 24 Weeks of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'comment': 'Patients completed the treatment phase of the study (on study for 52 weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Infusion Reaction (IR)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Adverse Event (Other than IR)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Elevated Serum Uric Acid', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation/Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'A total of 249 patients were screened at 66 of 112 activated clinical sites in the United States; 61 (24.5%) of the 249 patients were screen failures and 188 were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55.32', 'spread': '13.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '168', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Serum Uric Acid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.03', 'spread': '2.29', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Duration Since Initial Gout Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15.54', 'spread': '10.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Gout Flares in Last 6 Months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.60', 'spread': '12.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'flares', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-07-11', 'size': 1253083, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-29T12:06', 'hasProtocol': True}, {'date': '2018-03-25', 'size': 284221, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-29T12:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2011-10-28', 'resultsFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-29', 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Infusion Reactions', 'timeFrame': '52 weeks', 'description': 'Infusion reactions were defined as adverse events (AEs) or clusters of events, not attributable to another cause that occurred during or within 2 hours after the infusion of pegloticase. Any other case that occurred outside of the 2-hour window was categorized per Investigator discretion.'}, {'measure': 'Number of Participants With Anaphylaxis', 'timeFrame': '52 weeks', 'description': "Anaphylaxis was defined using the National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network (NIAID/FAAN) criteria: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives; pruritus or flushing; swollen lips, tongue, or uvula), and at least 1 of the following:\n\n1. Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia).\n2. Reduced blood pressure (i.e., systolic blood pressure \\< 90 mm Hg or greater than 30% decrease from that patient's baseline) or associated symptoms of end-organ failure (e.g., hypotonia \\[collapse\\], syncope, incontinence)."}, {'measure': 'Number of Participants With Immune Complex-related Events', 'timeFrame': 'From first dose of study drug to the end of the 12-week follow-up period (63 weeks).', 'description': 'Immune complex-related events were defined as any presumptive immune complex-related disorders that were confirmed by an appropriate investigation of the event and of complement markers (C3 and C4 levels). Clinical manifestations could have included skin rash, arthralgia, arthritis, proteinuria, serum sickness, and cryoglobulinemia.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Normalization of Serum Uric Acid at Week 24 and Week 52', 'timeFrame': 'Week 24 and week 52', 'description': 'Normalization of serum uric acid was defined as serum uric acid value less than 6 mg/dL.'}, {'measure': 'Change From Baseline in Number of Gout Flares', 'timeFrame': 'Baseline, week 24 and week 48', 'description': 'The number of gout flares occurring in the 2 weeks prior to each visit. Baseline number of flares was calculated as the average number of flares that occurred in the 6-month baseline period divided by 12 weeks.'}, {'measure': 'Number of Swollen Joints Over Time', 'timeFrame': 'Baseline and weeks 24 and 52'}, {'measure': 'Number of Tender Joints Over Time', 'timeFrame': 'Baseline and weeks 24 and 52'}, {'measure': 'Number of Palpable Tophi Over Time', 'timeFrame': 'Baseline and weeks 24 and 52', 'description': 'Gout tophi are nodular deposits of urate crystals and inflammatory cells in joints, soft tissues, bones, and in some organs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Refractory Chronic Gout']}, 'referencesModule': {'references': [{'pmid': '21846852', 'type': 'BACKGROUND', 'citation': 'Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, White WB, Lipsky PE, Horowitz Z, Huang W, Maroli AN, Waltrip RW 2nd, Hamburger SA, Becker MA. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011 Aug 17;306(7):711-20. doi: 10.1001/jama.2011.1169.'}], 'seeAlsoLinks': [{'url': 'https://www.krystexxa.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with pegloticase therapy will be identified.', 'detailedDescription': 'This was a Phase 4, multicenter, open-label, single-arm observational study of pegloticase 8 mg administered intravenously every 2 weeks in adult hyperuricemic patients with gout refractory to conventional therapy. Study duration is approximately 63 weeks, including 51 weeks of treatment and 12 weeks of follow-up.\n\nThe design of this study follows the FDA-approved Full Prescribing Information for the use of pegloticase and allows for capturing additional data related to the safety and efficacy of pegloticase within the standard healthcare setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population in this study will be hyperuricemic (serum uric acid (SUA) \\> 6 mg/dL) adult men and women (age 18 or greater) diagnosed with chronic gout and who are refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. To enter this study, the patient and the physician must have decided to begin treatment with KRYSTEXXA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age 18 years or more) with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated.\n* Patients who have made the decision, along with their treating physician, to begin treatment with KRYSTEXXA.\n* Patients who are willing and able to give informed consent and adhere to visit/protocol schedules.\n\nExclusion Criteria:\n\n* Glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* Non-compensated congestive heart failure\n* Pregnancy or breast feeding\n* Prior treatment with pegloticase or another recombinant uricase\n* Known allergy to urate oxidase\n* Prior treatment or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug\n* Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study'}, 'identificationModule': {'nctId': 'NCT01466166', 'acronym': 'EyesOnGOUT', 'briefTitle': 'Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Horizon Pharma Rheumatology LLC'}, 'officialTitle': 'Observational Study of the Use of KRYSTEXXA® (Pegloticase) in Adult Hyperuricemic Patients With Gout Refractory to Conventional Therapy', 'orgStudyIdInfo': {'id': 'M0401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pegloticase', 'description': 'Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.', 'interventionNames': ['Biological: Pegloticase']}], 'interventions': [{'name': 'Pegloticase', 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