Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06663618
Status:
RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Glucocorticoid Combined with MMF for IgG4-RD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], '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'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-26', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference of recurrent rate of IgG4-RD between the two groups', 'timeFrame': '72 weeks', 'description': 'Clinical recurrence definition: any item of IgG4-RD Responder Index \\>=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.'}], 'secondaryOutcomes': [{'measure': 'The time of recurrence', 'timeFrame': '0-72 weeks', 'description': 'Clinical recurrence definition: any item of IgG4-RD Responder Index \\>=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.'}, {'measure': 'The changes of IgG4-related disease Responder Index', 'timeFrame': '72 weeks', 'description': 'According to international multispecialty validation study of IgG4-related disease Responder Index (November, 2018), Responder Index ≥ 0, and higher scores mean a worse outcome.'}, {'measure': 'The changes of serum IgG4 levels', 'timeFrame': '72 weeks', 'description': 'Level of serum IgG4(mg/dL)'}, {'measure': 'The percentages of adverse events', 'timeFrame': '72 weeks', 'description': 'Adverse effect of drugs'}, {'measure': 'The changes of PGA', 'timeFrame': '72 weeks', 'description': 'Changes of patient global assessment from baseline, score (0-10, higher is worse)'}, {'measure': 'The difference of remission rate of IgG4-RD between the two groups', 'timeFrame': '72 weeks', 'description': 'Including complete remission rate, partial remission rate and total response rate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IgG4-related disease'], 'conditions': ['IgG4-related Disease']}, 'descriptionModule': {'briefSummary': 'Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease', 'detailedDescription': 'This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-80 years old;\n2. All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019;\n3. Active IgG4-RD (at least one organ has an IgG4-RD reaction score \\>=2 at the time of enrollment.)；\n4. No previous medication or recurrence after withdrawal.\n\nExclusion Criteria:\n\n1. Combined with other autoimmune diseases as the main diagnosis.\n2. Pregnant or lactating women\n3. Patients with malignant tumor\n4. Active bacterial, fungal, viral or mycobacterial infections.\n5. Severe complications of important organs, and the expected survival time is less than 6 months.'}, 'identificationModule': {'nctId': 'NCT06663618', 'briefTitle': 'Short-term Glucocorticoid Combined with MMF for IgG4-RD', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease', 'orgStudyIdInfo': {'id': 'MMF for IgG4-RD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'short-term glucocorticoid monotherapy', 'description': 'Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.', 'interventionNames': ['Drug: prednison']}, {'type': 'EXPERIMENTAL', 'label': 'short-term glucocorticoid combined with Mycophenolate mofetil', 'description': 'Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months.', 'interventionNames': ['Drug: prednison', 'Drug: Mycophenolate mofetil']}], 'interventions': [{'name': 'prednison', 'type': 'DRUG', 'description': 'Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.', 'armGroupLabels': ['short-term glucocorticoid combined with Mycophenolate mofetil', 'short-term glucocorticoid monotherapy']}, {'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'description': 'Oral Mycophenolate mofetil 0.75g bid for 6 months.', 'armGroupLabels': ['short-term glucocorticoid combined with Mycophenolate mofetil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linyi Peng, MD', 'role': 'CONTACT', 'email': 'drpenglinyi@163.com', 'phone': '8615810395901'}, {'name': 'Wen Zhang, MD', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Linyi Peng, MD', 'role': 'CONTACT', 'email': 'drpenglinyi@163.com', 'phone': '8615810395901'}], 'overallOfficials': [{'name': 'Wen Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wen Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wen Zhang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}