Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT01014260
Status:
WITHDRAWN
Last Update Posted:
2012-03-30
First Post:
2009-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxycycline Outcomes in Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'We could not get funding for study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-29', 'studyFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2009-11-13', 'lastUpdatePostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inflammatory markers of cardiovascular disease'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a clinical diagnosis of SLE, with a hs-CRP above \\> 3mg/L, (high risk level) for the last 3 months, are eligible.\n2. Patients must be 18 years of age or older and able to give informed consent.\n3. Contraception other than OCPs is necessary if a woman is at risk for pregnancy.\n\nExclusion Criteria:\n\n1. SLE patients who are allergic to doxycycline or other tetracyclines.\n2. Patients who are pregnant or are planning to become pregnant.\n3. Patients who are on oral contraceptives (any method of contraception other than OCPs can be used.\n4. Tetracycline use within the previous 2 weeks of enrollment.\n5. Patients who are currently on statins will be excluded, because statins might reduce hs- CRP.\n6. Patients who are on warfarin.\n7. Patients whose most recent EKG shows significant cardiac dysrhythmias or heart block.'}, 'identificationModule': {'nctId': 'NCT01014260', 'briefTitle': 'Doxycycline Outcomes in Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Doxycycline Outcomes in Lupus Erythematosus: (DOLE)', 'orgStudyIdInfo': {'id': 'NA_00001755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline', 'description': 'Doxycycline', 'interventionNames': ['Drug: Doxycycline']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'This is a randomized double-blind clinical trial of doxycycline 20 mg bid versus 100mg bid versus placebo, given for 3 months, to be conducted at a single center (JHH).', 'armGroupLabels': ['Placebo']}, {'name': 'Doxycycline', 'type': 'DRUG', 'description': 'Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo', 'armGroupLabels': ['Doxycycline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University SOM. 1830 East Monument St, Ste 7500', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Michelle Petri, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Michelle Petri', 'oldOrganization': 'Johns Hopkins University'}}}}