Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-30 @ 4:02 AM
Study NCT ID:
NCT00931957
Status:
UNKNOWN
Last Update Posted:
2010-11-22
First Post:
2009-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D031300', 'term': 'Retinal Vasculitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-19', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2010-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis', 'timeFrame': 'One Year'}], 'secondaryOutcomes': [{'measure': 'DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index', 'timeFrame': 'One Year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Etanercept', "Behcet's syndrome", "Behcet's Disease", 'Ocular Lesions', 'Uveitis', 'Retinal Vasculitis'], 'conditions': ['Behcet Syndrome', 'Uveal Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Melikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-α blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400"}, {'pmid': '12918769', 'type': 'BACKGROUND', 'citation': "Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behcet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. doi: 10.1007/0-306-48382-3_118. No abstract available."}, {'type': 'BACKGROUND', 'citation': "Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145"}, {'type': 'BACKGROUND', 'citation': "Davatchi F, Shams H, Nadji A, Jamshidi AR, Akhlaghi M, Sadeghi Abdollahi B, Ziaie N, Akbarian M, Gharibdoost F. Management of ocular manifestations of Behcet's Disease: outcome with cytotoxic drugs. APLAR Journal of Rheumatology 2005; 8: 119-123"}], 'seeAlsoLinks': [{'url': 'http://rrc.tums.ac.ir/', 'label': 'Rheumatology Research Center, Medical Sciences/University of Tehran'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone", 'detailedDescription': "To test in a randomized single blind control trial the efficacy of Etanercept in patients with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with Methotrexate and prednisolone"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)\n* Active posterior uveitis and/or retinal vasculitis\n\nExclusion Criteria:\n\n* Visual acuity inferior to 1/10 on Snellen chart\n* Being under cytotoxic drugs or having received them in the past 2 months\n* Not being able to follow the one year treatment and the regular follow ups"}, 'identificationModule': {'nctId': 'NCT00931957', 'briefTitle': "Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': "Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease", 'orgStudyIdInfo': {'id': '860241-5807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Etanercept-MTX-Prednisolone', 'description': 'Methotrexate + Prednisolone + Etanercept', 'interventionNames': ['Drug: Etanercept, Methotrexate, Prednisolone']}, {'type': 'OTHER', 'label': 'B, MTX-Prednisolone', 'description': 'Methotrexate + Prednisolone', 'interventionNames': ['Drug: Etanercept, Methotrexate, Prednisolone']}], 'interventions': [{'name': 'Etanercept, Methotrexate, Prednisolone', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': "In: Arm A, Etanercept-MTX-Prednisolone:\n\nEtanercept 50 mg weekly (subcutaneous injection) for 12 months. Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses.\n\nIn Arm B:\n\nMethotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses.", 'armGroupLabels': ['B, MTX-Prednisolone', 'Etanercept-MTX-Prednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14114', 'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Fereydoun Davatchi, MD', 'role': 'CONTACT', 'email': 'fddh@davatchi.net', 'phone': '(98-21)8802-6956'}, {'name': 'Bahar Sadeghi, MD', 'role': 'CONTACT', 'email': 'bahar@bahars.net', 'phone': '(98-21)8802-6956'}, {'name': 'Fereydoun Davatchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Farhad Shahram, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hormoz Shams, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abdolhadi Nadji, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bahar Sadeghi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Massoomeh Akhlaghi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tahereh Faezi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)", 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Fereydoun Davatchi, MD', 'role': 'CONTACT', 'email': 'fddh@davatchi.net', 'phone': '(98-21) 8802-6956'}, {'name': 'Bahar Sadeghi, MD', 'role': 'CONTACT', 'email': 'bahar@bahars.net', 'phone': '(98-21) 8820-6956'}], 'overallOfficials': [{'name': 'Fereydoun Davatchi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rheumatology Research Center, Medical Sciences/University of Teheran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Fereydoun Davatchi, Head Rheumatology Research Center', 'oldOrganization': 'Rheumatology Research Center, Tehran University for Medical Sciences'}}}}