Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-02 @ 2:07 AM
Study NCT ID:
NCT05375435
Status:
UNKNOWN
Last Update Posted:
2022-05-26
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080903', 'term': 'Dual Anti-Platelet Therapy'}], 'ancestors': [{'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RPILD', 'timeFrame': '6 months', 'description': 'Incidence of RP-ILD in patients after 6 months of treatment'}, {'measure': 'Death', 'timeFrame': '6 months', 'description': 'Mortality rate in patients after 6 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatomyositis, Adult Type', 'Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'We conduct this study to investigate the efficacy of triple therapy (high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor) compared with dual-therapy regimens (high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor) and whether it reduces the risk of poor pulmonary prognosis in patients with moderate to high risk anti-MDA5+ DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter\n* Anti-MDA5 Antibody-positive\n\nExclusion Criteria:\n\n* Complicated with other connective tissue diseases\n* Complicated with cardiovascular and respiratory disease caused by other reasons\n* Interstitial lung disease caused by environment and drugs\n* Patients with key research missing data or without informed consent'}, 'identificationModule': {'nctId': 'NCT05375435', 'briefTitle': 'Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Efficacy and Safety of Triple Therapy Based on Prognostic Risk Stratification in Patients With Anti-MDA5 Antibody-positive Dermatomyositis: a Multicenter, Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'TT-MDA5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Drug: triple therapy']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'interventionNames': ['Drug: dual-therapy']}], 'interventions': [{'name': 'triple therapy', 'type': 'DRUG', 'description': 'high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor', 'armGroupLabels': ['experimental group']}, {'name': 'dual-therapy', 'type': 'DRUG', 'description': 'high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenfeng Tan, PhD, MD', 'role': 'CONTACT', 'email': 'tanwenfeng@jsph.org.cn', 'phone': '086 18061202878'}, {'name': 'Hanxiao You, PhD, MD', 'role': 'CONTACT', 'email': 'youhanxiao@jsph.org.cn', 'phone': '086 18800181269'}], 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Wenfeng Tan', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}