Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-15 @ 3:50 PM
Study NCT ID:
NCT03770702
Status:
RECRUITING
Last Update Posted:
2018-12-10
First Post:
2018-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statins and ARBs on Rheumatoid Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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': 'D057911', 'term': 'Angiotensin Receptor Antagonists'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'C000616511', 'term': 'ORANGE protein, Arabidopsis'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-07', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in disease activity score', 'timeFrame': '6 months', 'description': 'DAS28-ESR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Investigational and comparative study between the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients', 'detailedDescription': 'The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis.\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Hepatic or renal impairment.'}, 'identificationModule': {'nctId': 'NCT03770702', 'briefTitle': 'Statins and ARBs on Rheumatoid Activity', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients', 'orgStudyIdInfo': {'id': 'Rheumatoid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Angiotensin receptor blockers', 'description': 'ARB ( Angiotensin receptor blockers) + Traditional therpy.', 'interventionNames': ['Drug: Angiotensin receptor blockers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Statins', 'description': 'Statin + Traditional therapy.', 'interventionNames': ['Drug: Statins']}], 'interventions': [{'name': 'Angiotensin receptor blockers', 'type': 'DRUG', 'otherNames': ['Cansartan'], 'description': 'Candesartan', 'armGroupLabels': ['Angiotensin receptor blockers']}, {'name': 'Statins', 'type': 'DRUG', 'otherNames': ['Ator'], 'description': 'Atorvastatin', 'armGroupLabels': ['Statins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed El-Abd, Msc', 'role': 'CONTACT'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, Ph D', 'role': 'CONTACT', 'email': 'sheriefabdelsalam@yahoo.com', 'phone': '00201147773440'}], 'overallOfficials': [{'name': 'Sahar K Hegazy, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Clinical Pharmacy Department'}, {'name': 'Tarek M Mostafa, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Prof of Clinical Pharmacy'}, {'name': 'Emad M Elshebini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rheumatology Dept. - Menoufia University'}, {'name': 'Ahmed HM El-Abd, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical pharmacy Department-Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof. Tropical Medicine', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}