Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT05781516
Status:
UNKNOWN
Last Update Posted:
2023-03-27
First Post:
2023-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077733', 'term': 'Immunoglobulin G4-Related Disease'}, {'id': 'D004802', 'term': 'Eosinophilia'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'C000596027', 'term': 'baricitinib'}], 'ancestors': [{'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': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2023-03-12', 'studyFirstSubmitQcDate': '2023-03-12', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference of recurrent rate of IgG4-RD between the two groups', 'timeFrame': '52 weeks', 'description': 'Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.'}], 'secondaryOutcomes': [{'measure': 'The time of recurrence', 'timeFrame': '0-52 weeks', 'description': 'Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.'}, {'measure': 'The changes of IgG4-related disease Responder Index', 'timeFrame': '52 weeks', 'description': 'According to international multispecialty validation study of IgG4-related disease Responder Index (Version: 13, December, 2015), Responder Index ≥ 0, and higher scores mean a worse outcome.'}, {'measure': 'The changes of blood Eosinophil cells', 'timeFrame': '52 weeks', 'description': 'Percentages (%) and counts (109) of peripheral eosinophil cells'}, {'measure': 'The changes of serum IgG levels', 'timeFrame': '52 weeks', 'description': 'Level of serum IgG(g/L)'}, {'measure': 'The changes of serum IgG4 levels', 'timeFrame': '52 weeks', 'description': 'Level of serum IgG4(mg/dL)'}, {'measure': 'The changes of serum hsCRP level', 'timeFrame': '52 weeks', 'description': 'Level of serum high-sensitivity C-reactive protein level(mg/L)'}, {'measure': 'The changes of ESR', 'timeFrame': '52 weeks', 'description': 'Serum erythrocyte sedimentation rate(mm/h)'}, {'measure': 'The percentages of adverse events', 'timeFrame': '52 weeks', 'description': 'Adverse effect of drugs'}, {'measure': 'The changes of PGA', 'timeFrame': '52 weeks', 'description': 'Changes of patient global assessment from baseline, score (0-10, higher is worse)'}, {'measure': 'The results of High-throughput analysis', 'timeFrame': '52 weeks', 'description': 'The changes of results from baseline in High-throughput analysis, including GWAS, single cell sequencing of B cell receptor.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IgG4-related disease', 'eosinophilia'], 'conditions': ['IgG4-related Disease With Eosinophilia']}, 'descriptionModule': {'briefSummary': 'Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.', 'detailedDescription': 'This is a multicenter, 52-week prospective, randomized controlled study to compare the efficacy and safety of Baricitinib combined with glucocorticoid and glucocorticoid monotherapy in proliferative IgG4-RD patients with eosinophilia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients must meet the following diagnostic criteria of IgG4RD (2020): 1) and radiological features: One or more organs show diffuse or localized swelling or a mass or nodule characteristic of IgG4-RD. In single organ involvement, lymph node swelling is omitted. 2) serological diagnosis: Serum IgG4 levels greater than 135 mg/dl. 3) diagnosis diagnosis: Positivity for two of the following three criteria: a. Dense lymphocyte and plasma cell infiltration with fibrosis. b. Ratio of IgG4-positive plasma cells /IgG-positive cells greater than 40% and the number of IgG4-positive plasma cells greater than 10 per high powered field. c. Typical tissue fibrosis, particularly storiform fibrosis, or obliterative phlebitis.\n\n Patients fulfill (1) + (2) + (3) are diagnosed as definite IgD4RD; (1) + (2): possible IgG4RD; (1) + (3): probable IgG4RD. exclusion of other diseases.\n2. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)\n3. The counts of peripheral blood eosinophil cells ≥0.75×109/L\n\nExclusion Criteria:\n\n1. Patients who is not able to discontinue GC\n2. Pregnancy or breastfeeding or planning to get pregnant within 2 years\n3. Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months\n4. Allergic to Baricitinib\n5. Concomitant other autoimmune diseases\n6. Malignancy\n7. Chronic HBV infection, latent tuberculosis, or active infection\n8. Server liver or renal dysfunction, or heart failure.'}, 'identificationModule': {'nctId': 'NCT05781516', 'briefTitle': 'Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Prospective, Randomized Controlled Study to Compare the Efficacy and Safety of Baricitinib Combined With Glucocorticoid and Glucocorticoid Monotherapy in Proliferative IgG4-RD Patients With Eosinophilia', 'orgStudyIdInfo': {'id': 'Baricitinib for Eosinophilia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Prednisolone monotherapy', 'description': 'Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.', 'interventionNames': ['Drug: Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Prednisolone plus Baricitinib', 'description': 'Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. Oral Baricitinib 2mg daily for 12 months.', 'interventionNames': ['Drug: Prednisolone', 'Drug: Baricitinib']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.', 'armGroupLabels': ['Prednisolone monotherapy', 'Prednisolone plus Baricitinib']}, {'name': 'Baricitinib', 'type': 'DRUG', 'description': 'Oral Baricitinib 2mg daily for 12 months.', 'armGroupLabels': ['Prednisolone plus Baricitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Bejing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linyi Peng, MD', 'role': 'CONTACT', 'email': 'drpenglinyi@163.com', 'phone': '+8615810395901'}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wen Zhang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wen Zhang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}