Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-31 @ 2:31 AM
Study NCT ID:
NCT04808856
Status:
UNKNOWN
Last Update Posted:
2021-03-22
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Refractory Gout With ACTH or Methylprednisolone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000324', 'term': 'Adrenocorticotropic Hormone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of pain', 'timeFrame': '7 days', 'description': 'Visual analogue scale (VAS 0-10)'}, {'measure': 'Arthritis score', 'timeFrame': '7 days', 'description': 'Arthritis (redness and swelling fever 0-3) score'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '1 month', 'description': 'Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.', 'detailedDescription': 'When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated . From the current clinical research evidence , we have seen the non-inferior effect of ACTH on glucocorticoids and non-steroidal anti-inflammatory drugs in the treatment of acute gout , as well as the good safety and extensive anti-inflammatory effect in addition to efficacy . Therefore , we designed this study to update and improve the treatment of acute gout attacks , and to try to clarify the mechanism of action .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (123 items and 1 item from 4-7 are met simultaneously) :\n\n 1. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout\n 2. Acute gouty arthritis\n 3. Age ≥18\n 4. Repeated attacks and prolonged pain (more than 1 month);\n 5. poor response or intolerance to colchicine or NSAIDs;\n 6. Liver and kidney dysfunction;\n 7. Old age;\n\nExclusion Criteria:\n\n* 1\\) History of gastrointestinal bleeding and active ulcer 2) The application history of glucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4) Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6) Mental illness inability to communicate or have language barriers and inability to fully understand and cooperate 7) negligent compensatory heart failure, unstable angina pectoris, stroke, transient ischemic attack, myocardial infarction, and severe arrhythmia occurred within 6 months 8) The investigator did not consider it appropriate to participate in the study'}, 'identificationModule': {'nctId': 'NCT04808856', 'briefTitle': 'Treatment of Refractory Gout With ACTH or Methylprednisolone', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone', 'orgStudyIdInfo': {'id': 'ACTH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACTH', 'description': 'Adrenocorticotropic Hormone', 'interventionNames': ['Drug: Adrenocorticotropic Hormone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Methylprednisolone', 'interventionNames': ['Drug: Methylprednisolone Injection']}], 'interventions': [{'name': 'Adrenocorticotropic Hormone', 'type': 'DRUG', 'description': 'Adrenocorticotropic Hormone Injection 25u qd iv \\*3d', 'armGroupLabels': ['ACTH']}, {'name': 'Methylprednisolone Injection', 'type': 'DRUG', 'description': 'Methylprednisolone Injection 40mg qd iv \\*3d', 'armGroupLabels': ['Methylprednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200070', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hang Sun, MD', 'role': 'CONTACT', 'email': 'sunhang1027@126.com', 'phone': '86-21-66301004'}], 'facility': "Shanghai Tenth People's hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hang Sun, MD', 'role': 'CONTACT', 'email': 'sunhang1027@126.com', 'phone': '86-21-66301004'}, {'name': 'Shen Qu, M.D Ph.D', 'role': 'CONTACT', 'phone': '86-21-66301004'}], 'overallOfficials': [{'name': 'Shen Qu, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Tenth People' Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}