Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-27 @ 2:13 PM
Study NCT ID:
NCT01758393
Status:
UNKNOWN
Last Update Posted:
2013-01-01
First Post:
2012-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucocorticoids in Patients With IgG4-RD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-06-23', 'releaseDate': '2017-04-07'}, {'resetDate': '2018-01-29', 'releaseDate': '2017-07-06'}], 'estimatedResultsFirstSubmitDate': '2017-04-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077733', 'term': 'Immunoglobulin G4-Related Disease'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-24', 'studyFirstSubmitDate': '2012-12-24', 'studyFirstSubmitQcDate': '2012-12-24', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response', 'timeFrame': '3 months', 'description': 'Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.'}], 'secondaryOutcomes': [{'measure': 'Disease Response', 'timeFrame': '3 months', 'description': 'Disease Response is measured by IgG4-RD Responder Index(IgG4-RD RI) and defined as:\n\n* Improvement of \\> 2 points in the IgG4-RD RI over baseline\n* No disease flares, as assessed by the IgG4-RD RI.'}, {'measure': 'Adverse Effect', 'timeFrame': '3 months', 'description': 'Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IgG4-related disease', 'IgG4-RD'], 'conditions': ['IgG4-related Disease']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Age 18-70 years old with informed consent\n* Patients with IgG4-RD:\n\n 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;\n 2. elevated serum IgG4 (\\>1.35 g/L)\n 3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);\n 4. exclusion of other diseases.\n\nExclusion Criteria:\n\n* Previously or currently received glucocorticoid and(or) immunomodulator\n* Pregnancy or lactating\n* Concurrent severe and/or uncontrolled and/or unstable diseases\n* Patient with malignancy'}, 'identificationModule': {'nctId': 'NCT01758393', 'briefTitle': 'Glucocorticoids in Patients With IgG4-RD', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease', 'orgStudyIdInfo': {'id': 'PUMCH-GC-IgG4RD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medium Dose', 'description': 'Patients are treated with prednisone or equivlent at doseage of 0.5-0.6 mg/kg/d (max 40mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.', 'interventionNames': ['Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose', 'description': 'Patients are treated with prednisone or equivlent at doseage of 0.8-1.0 mg/kg/d (max 60mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.', 'interventionNames': ['Drug: Prednisone']}], 'interventions': [{'name': 'Prednisone', 'type': 'DRUG', 'armGroupLabels': ['High Dose', 'Medium Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Zhang, MD', 'role': 'CONTACT', 'email': 'zhangwen91@sina.com', 'phone': '+86-10-69158795'}, {'name': 'Hua Chen, MD', 'role': 'CONTACT', 'email': 'chenhua@pumch.cn', 'phone': '+86-10-69158797'}], 'facility': 'Deptment of Rheumatology, Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hua Chen, MD', 'role': 'CONTACT', 'email': 'chenhua@pumch.cn', 'phone': '+86-10-69158797'}], 'overallOfficials': [{'name': 'Wen Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deptment of Rheumatology, Peking Union Medical College Hospital'}, {'name': 'Fengchun Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'Deptment of Rheumatology, Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wen Zhang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-07', 'type': 'RELEASE'}, {'date': '2017-06-23', 'type': 'RESET'}, {'date': '2017-07-06', 'type': 'RELEASE'}, {'date': '2018-01-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Wen Zhang, Professor, Peking Union Medical College Hospital'}}}}