Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-02-20 @ 4:43 PM
Study NCT ID:
NCT03023592
Status:
UNKNOWN
Last Update Posted:
2017-01-18
First Post:
2017-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Iguratimod in Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C519076', 'term': 'iguratimod'}, {'id': 'C077313', 'term': 'T 614'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-15', 'studyFirstSubmitDate': '2017-01-15', 'studyFirstSubmitQcDate': '2017-01-15', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ESSDAI improvement', 'timeFrame': 'week 24', 'description': "The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks."}, {'measure': 'ESSPRI improvement', 'timeFrame': 'week 24', 'description': "The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks."}], 'secondaryOutcomes': [{'measure': 'Unstimulated salivary flow rate', 'timeFrame': 'week 24', 'description': 'The change from baseline in unstimulated salivary flow rate at 24 weeks.'}, {'measure': "Schimer's test", 'timeFrame': 'week 24', 'description': "The change from baseline in Schimer's test at 24 weeks."}, {'measure': 'SF-36', 'timeFrame': 'week 24', 'description': 'The change from baseline in SF-36 score at 24 weeks.'}, {'measure': 'HAQ', 'timeFrame': 'week 24', 'description': 'The change from baseline in HAQ score at 24 weeks.'}, {'measure': 'Immunoglobulins', 'timeFrame': 'week 24', 'description': 'The change from baseline in IgG, IgM and IgA levels at 24 weeks.'}, {'measure': 'Rheumatoid Factors', 'timeFrame': 'week 24', 'description': 'The change from baseline in titer of rheumatoid factors at 24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Sjogren's Syndrome", 'Iguratimod'], 'conditions': ["Sjogren's Syndrome"]}, 'descriptionModule': {'briefSummary': "A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome", 'detailedDescription': "In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria\n* Positive dry eyes and (or) dry mouth symptoms\n* Hyperglobulinemia\n\nExclusion Criteria:\n\n* Complicated with other systemic autoimmune diseases\n* Severe complications of Sjogren's syndrome\n* Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit\n* Active infections or chronic infectious diseases\n* A history of malignancies\n* Pregnancy or breathfeeding\n* Inability to comply with the study protocol for any other reason"}, 'identificationModule': {'nctId': 'NCT03023592', 'briefTitle': "Study of Iguratimod in Sjögren's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': "A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'PUMCH170115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iguratimod', 'description': 'Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.', 'interventionNames': ['Drug: Iguratimod']}], 'interventions': [{'name': 'Iguratimod', 'type': 'DRUG', 'otherNames': ['T-614'], 'description': 'Iguratimod 25 mg orally twice a day for 24 weeks', 'armGroupLabels': ['Iguratimod']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Chen, Dr.', 'role': 'CONTACT', 'email': 'chenhua@pumch.cn', 'phone': '86-10-69158797'}, {'name': 'Yan Zhao, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hua Chen, Dr.', 'role': 'CONTACT', 'email': 'chenhua@pumch.cn', 'phone': '86-10-69158797'}], 'overallOfficials': [{'name': 'Yan Zhao, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}