Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-04-20 @ 4:54 AM
Study NCT ID:
NCT03192657
Status:
UNKNOWN
Last Update Posted:
2017-06-20
First Post:
2017-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Basiliximab Treating Interstitial Pneumonia of CADM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D003882', 'term': 'Dermatomyositis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'D065095', 'term': 'Calcineurin Inhibitors'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-18', 'studyFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2017-06-18', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '52 week'}], 'secondaryOutcomes': [{'measure': 'Forced vital capacity', 'timeFrame': '52 week', 'description': 'measured with lung function test equipment'}, {'measure': 'Total lung capacity', 'timeFrame': '52 week', 'description': 'measured with lung function test equipment'}, {'measure': 'Diffusing capacity', 'timeFrame': '52 week', 'description': 'transfer factor of the lung for carbon monoxide, measured with lung function test equipment.'}, {'measure': 'Lung CT change', 'timeFrame': '52 week', 'description': 'Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated.'}, {'measure': 'Serum ferritin', 'timeFrame': '52 week'}, {'measure': 'Serum KL-6', 'timeFrame': '52 week', 'description': 'A new biomarker of alveolar injury.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung; Disease, Interstitial, With Fibrosis', 'Dermatomyositis']}, 'descriptionModule': {'briefSummary': 'This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.\n* Agreement of contraception.\n* Serum creatine Kinase ≤ 1.5 fold of upper normal level.\n* Interstitial pneumonia:\n\n(meet at least two in four of following)\n\n1. interstitial pneumonia images in high resolution CT;\n2. DLCO (diffusing capacity)≤ 60% predict in lung function test;\n3. elevated serum KL-6;\n4. serum anti-MDA5 (+).\n\nExclusion Criteria:\n\n* Previous application of immunosuppressives or any target treatment for dermatomyositis.\n* Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).\n* Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.\n* Abnormal renal function at screening (serum creatine\\>300μmol/L，or eGFR\\<60mL/min/1.73m2, or end-stage renal disease).\n* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.\n* History of any malignancy.'}, 'identificationModule': {'nctId': 'NCT03192657', 'briefTitle': 'Basiliximab Treating Interstitial Pneumonia of CADM', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients', 'orgStudyIdInfo': {'id': 'ADM01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basiliximab group', 'description': '1. Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset.\n2. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.\n3. Steroids: 1mg/kg/d, calculated with prednisone.', 'interventionNames': ['Drug: Basiliximab', 'Drug: Calcineurin Inhibitors', 'Drug: Steroids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': '1. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.\n2. Steroids: 1mg/kg/d, calculated with prednisone.', 'interventionNames': ['Drug: Calcineurin Inhibitors', 'Drug: Steroids']}], 'interventions': [{'name': 'Basiliximab', 'type': 'DRUG', 'description': 'The first administration should be within 8 weeks after disease onset.', 'armGroupLabels': ['Basiliximab group']}, {'name': 'Calcineurin Inhibitors', 'type': 'DRUG', 'description': 'Researchers can choose cyclosporin A or tacrolimus according to patient tolerance. Either agent should be applied promptly once infection is ruled out for a patient.', 'armGroupLabels': ['Basiliximab group', 'control group']}, {'name': 'Steroids', 'type': 'DRUG', 'description': 'Dosage of steroid can be adjusted according to personal experience of the researcher.', 'armGroupLabels': ['Basiliximab group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'RenJi Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}