Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-02 @ 5:09 AM
Study NCT ID:
NCT00675103
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D015210', 'term': 'Arthritis, Gouty'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '732-418-9300', 'title': 'Chief Medical Officer', 'organization': 'Savient Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Pegloticase 8 mg Every 2 Wks', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Infusion-Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Gout (flare)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Diabete Mellitus Non-Insulin Dependent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'New Tophus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Wound Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Event Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase 8 mg Every 2 Wks'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants reporting events', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Plasma Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegloticase 8 mg Every 2 Wks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.5', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '7.7', 'spread': '5.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3 and Week 7', 'description': 'This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegloticase 8 mg Every 2 Wks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegloticase 8 mg Every 2 Wks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '8.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-07', 'studyFirstSubmitDate': '2008-05-06', 'resultsFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2008-05-07', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-07', 'studyFirstPostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event Profile', 'timeFrame': '6 months', 'description': 'Number of participants reporting events'}], 'secondaryOutcomes': [{'measure': 'Mean Plasma Uric Acid', 'timeFrame': 'Baseline, Week 3 and Week 7', 'description': 'This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gout', 'Gouty Arthritis', 'Anti-Gout preparations'], 'conditions': ['Chronic Gout Refractory to Conventional Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.\n\nThis study is limited to four study centers in the US.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous treatment in studies of pegloticase i.v.\n* Last exposure to pegloticase i.v. greater than one year prior to study entry\n* Symptomatic gout\n* Documented hyperuricemic (SUA ≥ 7 mg/dL)\n\nExclusion Criteria:\n\n* Prior exposure to Elitek® (rasburicase)\n* Unstable angina\n* Uncontrolled arrhythmia or hypertension\n* Non-compensated congestive heart failure\n* End stage renal disease requiring dialysis\n* Concomitant use of SUA lowering agents and use of other investigational drugs'}, 'identificationModule': {'nctId': 'NCT00675103', 'briefTitle': 'Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Savient Pharmaceuticals'}, 'officialTitle': 'Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.', 'orgStudyIdInfo': {'id': 'C0409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pegloticase', 'interventionNames': ['Drug: pegloticase 8 mg i.v.']}], 'interventions': [{'name': 'pegloticase 8 mg i.v.', 'type': 'DRUG', 'description': 'pegloticase 8 mg i.v. every 2 weeks for 24 weeks', 'armGroupLabels': ['pegloticase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago- Dept. Biological Services', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Rheumatology and Bone Research', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97035', 'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Rheumatology Clinic, L.L.C.', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Savient Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Savient Pharmaceuticals'}}}}