Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT01101802
Status:
COMPLETED
Last Update Posted:
2011-09-28
First Post:
2010-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'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'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-27', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2010-04-09', 'lastUpdatePostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow mediated dilation', 'timeFrame': '8 weeks', 'description': 'Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.'}], 'secondaryOutcomes': [{'measure': 'BILAG, SLEDAI,', 'timeFrame': '8 weeks', 'description': 'Measurements of disease activity in SLE'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SLE', 'Atherosclerosis', 'Endothelial function', 'Mycophenolate mofetil'], 'conditions': ['Systemic Lupus Erythematosus', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female SLE patients\n* Age 18-60 years\n* If premenopausal using a reliable method of contraception\n* Clinically stable disease\n* Taking hydroxychloroquine and up to 15mgs of prednisolone daily\n\nExclusion Criteria:\n\n* Smokers\n* Pregnancy or breast feeding\n* Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)\n* Use of any investigational drug within 1 month prior to screening\n* Acute infections 2 weeks prior to Visit 1\n* History of ischaemic heart disease or end stage renal disease\n* Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease'}, 'identificationModule': {'nctId': 'NCT01101802', 'acronym': 'MISSILE', 'briefTitle': 'Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': "A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.", 'orgStudyIdInfo': {'id': 'WX18694'}, 'secondaryIdInfos': [{'id': 'ISRCTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mycophenolate mofetil', 'description': 'Patients were given 1gm bd mycophenolate mofetil for 8 weeks', 'interventionNames': ['Drug: Mycophenolate mofetil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'interventionNames': ['Drug: sugar pill']}], 'interventions': [{'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['Cellcept'], 'description': 'Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.', 'armGroupLabels': ['Mycophenolate mofetil']}, {'name': 'sugar pill', 'type': 'DRUG', 'description': 'Arm 2 patients were given 2 sugar pills bd for 8 weeks', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Lupus Research Unit, St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': "David P D'Cruz, MD, FRCP", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Child Health, University College London, London, UK.', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': "Dr David D'Cruz", 'oldOrganization': "Lupus Research Unit, St Thomas' hospital"}}}}