Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02703194
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2016-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leflunomide for Maintenance of Remission in IgG4 Related Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077733', 'term': 'Immunoglobulin G4-Related Disease'}, {'id': 'D008882', 'term': "Mikulicz' Disease"}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D012185', 'term': 'Retroperitoneal Fibrosis'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D000077339', 'term': 'Leflunomide'}], '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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2016-02-27', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse rate at 12 months.', 'timeFrame': '12 months', 'description': 'Relapse referred to the recurrence of previous clinical manifestations or abnormality of organ-specific imaging findings or serology tests after remission.'}], 'secondaryOutcomes': [{'measure': 'Relapse rate at 6 months.', 'timeFrame': '6 months', 'description': 'Relapse referred to the recurrence of previous clinical manifestations or abnormality of organ-specific imaging findings or serology tests after remission.'}, {'measure': 'Complete response assessed by IgG4-RD Responder Index (IgG4-RD RI) at 1, 3, 6 and 12 months.', 'timeFrame': 'Up to 12 months', 'description': 'Complete response (CR) is defined as IgG4-RD RI \\<3 at 1, 3, 6 and 12 months.'}, {'measure': 'Partial response assessed by IgG4-RD RI at 1, 3, 6 and 12 months.', 'timeFrame': 'Up to 12 months', 'description': 'Partial response (PR) is defined as IgG4-RD RI remaining ≥3 at 1, 3, 6 and 12 months.'}, {'measure': 'Serum IgG4 concentrations (mg/dL) measured by immunonephelometry at 1, 3, 6 and 12 months.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of circulating plasmablasts (cell number/mL) assessed by flow cytometry by gating peripheral blood at 1, 3, 6 and 12 months.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Adverse effect events', 'timeFrame': 'Up to 12 months', 'description': 'Treatment-related adverse effect, including abnormal liver function and leukopenia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IgG4-related disease', 'IgG4-related sclerosing cholangitis', 'Mikulicz disease', 'Pancreatitis', 'Retroperitoneal fibrosis', 'Lymphadenopathy'], 'conditions': ['Immunoglobulin G4 Related Sclerosing Disease']}, 'referencesModule': {'references': [{'pmid': '32113839', 'type': 'DERIVED', 'citation': 'Wang Y, Zhao Z, Gao D, Wang H, Liao S, Dong C, Luo G, Ji X, Li Y, Wang X, Zhao Y, Li K, Zhang J, Jin J, Zhang Y, Zhu J, Zhang J, Huang F. Additive effect of leflunomide and glucocorticoids compared with glucocorticoids monotherapy in preventing relapse of IgG4-related disease: A randomized clinical trial. Semin Arthritis Rheum. 2020 Dec;50(6):1513-1520. doi: 10.1016/j.semarthrit.2020.01.010. Epub 2020 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The study has been designed as a 12-month, open-label, randomized, controlled study comparing the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in treating patients with IgG4-related disease.', 'detailedDescription': 'The aim of this clinical trial is to determine the safety and efficacy of Leflunomide in treating patients with IgG4-related disease by comparing the outcomes of prednisone and leflunomide combination therapy with prednisone mono-therapy. The follow-up period will be 12 months. During the follow-up period, results of laboratory tests and image examinations, IgG4-RD RI and other parameters which can reflect treatment response as well as adverse effect events will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Diagnosis of IgG4-RD according to either Consensus statement on the pathology of IgG4-related disease (for those who have undergone biopsies) or 2011 Comprehensive diagnostic criteria for IgG4-related disease. Both of the two criteria for diagnosis are specified below.\n\n(1)Consensus statement on the pathology of IgG4-related disease\n\n1. Histopathologic features consisting of dense lymphoplasmacytic infiltrate, fibrosis(usually storiform in character)and/or obliterative phlebitis within involved organs.\n2. Either an elevated IgG4+/IgG+cell ratio of \\>40% within the affected organs or elevated IgG4-bearing plasma cells per high-power field is necessary. The cut-off number of IgG4-bearing plasma cells per high-power field is different depending upon the types of affected organs and specimens(through surgery or needle puncture biopsy).\n\n(2)2011 Comprehensive diagnostic criteria for IgG4-related disease\n\n1. Clinical examination showing characteristic diffuse/localized swelling or masses in single or multiple organs.\n2. Hematological examination shows elevated serum IgG4 concentrations(135 mg/dl).\n3. Histopathologic examination shows marked lymphocyte and plasmacyte infiltration and fibrosis or Infiltration of IgG4+ plasma cells(ratio of IgG4+/IgG+ cells \\> 40% and \\>10 IgG4+ plasma cells/HPF).\n\n Definite: a + b + c,Probable: a + c,Possible: a + b\n4. Excluded from malignant tumors of each organ (e.g. cancer, lymphoma) and similar diseases (e.g. Sjögren's syndrome, primary sclerosing cholangitis, Castleman's disease, secondary retroperitoneal fibrosis, Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome) by additional histopathological examination.\n5. Even when patients cannot be diagnosed using the Comprehensive diagnostic criteria, they may be diagnosed using organ-specific diagnostic criteria for IgG4-RD, such as Diagnostic criteria for IgG4-Mikulicz's disease.\n\nExclusion Criteria:\n\n1. Subjects having received steroids or immunosuppressants in recent 3 months will be excluded.\n2. Subjects who were hypersensitive to leflunomide will be excluded.\n3. ALT and/or AST is more than two folds of the upper limit of relevant reference value at baseline.\n4. WBC is less than 3×10\\*9/L at baseline.\n5. Female patients who are pregnant or breastfeeding.\n6. Known significant concurrent medical disease."}, 'identificationModule': {'nctId': 'NCT02703194', 'briefTitle': 'Leflunomide for Maintenance of Remission in IgG4 Related Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease', 'orgStudyIdInfo': {'id': 'ChinaPLAGH-IgG4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prednisone', 'description': 'Prednisone mono-therapy', 'interventionNames': ['Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Prednisone and Leflunomide', 'description': 'Prednisone and Leflunomide combination therapy', 'interventionNames': ['Drug: Prednisone', 'Drug: Leflunomide']}], 'interventions': [{'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Prednisolone'], 'description': 'Prednisone:A starting dose of 0. 5-0. 8mg/(kg\\*d) will be given. Following four-week period, the dose will be tapered gradually to 5mg/d until the end of 12 months of follow-up period.', 'armGroupLabels': ['Prednisone', 'Prednisone and Leflunomide']}, {'name': 'Leflunomide', 'type': 'DRUG', 'otherNames': ['ARAVA®'], 'description': 'Leflunomide:A starting dose of 20 mg/day will be given. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor adverse effects occur(e.g., liver enzyme elevations).', 'armGroupLabels': ['Prednisone and Leflunomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jian Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Rheumatology', 'investigatorFullName': 'Jian Zhu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}