Nctid:
NCT00001954
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012859", "term"=>"Sjogren's Syndrome"}, {"id"=>"D013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D001172", "term"=>"Arthritis, Rheumatoid"}, {"id"=>"D001168", "term"=>"Arthritis"}, {"id"=>"D007592", "term"=>"Joint Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D012216", "term"=>"Rheumatic Diseases"}, {"id"=>"D014987", "term"=>"Xerostomia"}, {"id"=>"D012466", "term"=>"Salivary Gland Diseases"}, {"id"=>"D009059", "term"=>"Mouth Diseases"}, {"id"=>"D009057", "term"=>"Stomatognathic Diseases"}, {"id"=>"D015352", "term"=>"Dry Eye Syndromes"}, {"id"=>"D007766", "term"=>"Lacrimal Apparatus Diseases"}, {"id"=>"D005128", "term"=>"Eye Diseases"}, {"id"=>"D003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M15664", "name"=>"Sjogren's Syndrome", "asFound"=>"Sjogren's Syndrome", "relevance"=>"HIGH"}, {"id"=>"M17724", "name"=>"Xerostomia", "relevance"=>"LOW"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M4480", "name"=>"Arthritis, Rheumatoid", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"M15285", "name"=>"Salivary Gland Diseases", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}, {"id"=>"M18040", "name"=>"Dry Eye Syndromes", "relevance"=>"LOW"}, {"id"=>"M10664", "name"=>"Keratoconjunctivitis Sicca", "relevance"=>"LOW"}, {"id"=>"M10786", "name"=>"Lacrimal Apparatus Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000068800", "term"=>"Etanercept"}], "ancestors"=>[{"id"=>"D000894", "term"=>"Anti-Inflammatory Agents, Non-Steroidal"}, {"id"=>"D018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}], "browseLeaves"=>[{"id"=>"M311", "name"=>"Etanercept", "asFound"=>"Planning", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4218", "name"=>"Anti-Inflammatory Agents, Non-Steroidal", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>28}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2003-11", "completionDateStruct"=>{"date"=>"2003-11"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"2000-01-18", "studyFirstSubmitQcDate"=>"2000-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2000-01-19", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Clinical Trial", "Autoimmune", "Disease Activity", "Cytokine", "Saliva", "Xerostomia", "Salivary Glands", "Sjogren's Syndrome"], "conditions"=>["Sjogren's Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3858368", "type"=>"BACKGROUND", "citation"=>"Fox PC, van der Ven PF, Sonies BC, Weiffenbach JM, Baum BJ. Xerostomia: evaluation of a symptom with increasing significance. J Am Dent Assoc. 1985 Apr;110(4):519-25. doi: 10.14219/jada.archive.1985.0384."}, {"pmid"=>"1323135", "type"=>"BACKGROUND", "citation"=>"Fox RI, Kang HI. Pathogenesis of Sjogren's syndrome. Rheum Dis Clin North Am. 1992 Aug;18(3):517-38."}, {"pmid"=>"8335784", "type"=>"BACKGROUND", "citation"=>"Atkinson JC, Fox PC. Sjogren's syndrome: oral and dental considerations. J Am Dent Assoc. 1993 Mar;124(3):74-6, 78-82, 84-6. doi: 10.14219/jada.archive.1993.0064."}]}, "descriptionModule"=>{"briefSummary"=>"This study will test the effectiveness of etanercept (Enbrel) for treating Sjogren's syndrome-an autoimmune disease that affects the secreting glands. (In autoimmune diseases, the immune system attacks the body's own tissues.) Reduced lacrimal (tear) gland function causes dry eyes with a scratchy sensation, and, in severe cases, vision be may impaired. Reduced salivary gland function causes dry mouth, resulting in greatly increased tooth decay. Dry mouth also makes chewing and swallowing difficult, which may lead to nutrition deficiencies. Sjogren's syndrome can also cause dryness of the skin and of mucous membranes in the nose, throat, airways, and vagina.\n\nPatients with Sjogren's syndrome who have had oral and eye examinations under NIDCR's protocol 84-D-0056 may participate in this study. Participants will be randomly assigned to receive either etanercept or placebo (an inactive look-alike substance) by injection under the skin twice a week for 3 months.\n\nPatients will be seen for evaluation before treatment begins (baseline) and again at 1, 3, and 4 months. The baseline and 3-month visits include a physical examination, eye examination, saliva collection from salivary glands, blood tests, and evaluation for changes in symptoms and treatment side effects. The 1- and 4-month visits include saliva collection, blood tests, and review of symptoms and treatment side effects. In addition, blood will be drawn every 2 weeks for safety monitoring. Patients will also be surveyed weekly (by telephone or during the clinic visit) about symptoms and treatment side effects.\n\nThe Food and Drug Administration has approved Enbrel for treating certain forms of arthritis, which, like Sjogren's syndrome, are autoimmune disorders of the connective tissue. Laboratory studies also indicate that etanercept may be an effective treatment for Sjogren's syndrome.", "detailedDescription"=>"Sjogren's syndrome (SS) is an autoimmune disease chiefly affecting the exocrine glands. Manifestations of SS include salivary and lacrimal gland dysfunction. There is no generally accepted treatment for the underlying autoimmune reactivity or the exocrine gland dysfunction in SS. We propose to test the effects of etanercept therapy. In a randomized, double-masked, outpatient protocol, patients will receive etanercept for 2 times/week for 3 months. Therapy will be given by subcutaneous injection. Efficacy of treatment will be assessed by monitoring salivary and lacrimal function, serological markers of autoimmune activity, and subjective reports of local and systemic symptoms. The present trial will serve as a screening protocol to identify if etanercept should be further analyzed in a larger clinical trial for efficacy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"INCLUSION CRITERIA\n\nDocumented primary or secondary SS.\n\nAbsence of confounding health problems.\n\nNo contraindications to etanercept therapy.\n\nSS patients cannot have sarcoidosis, HIV infection, or lymphoma.\n\nPatients must have one of the following abnormal autoimmune serologies associated with SS (i.e. positive ANA, RF, and anti-SS-A, or anti-SS-B).\n\nPatients may use pilocarpine provided that they hold their dose on visit days when saliva is collected.\n\nPatients taking DMARD's, such as hydroxychloroquine, must be on a stable dose.\n\nParticipants may take NSAIDs or acetaminophen.\n\nEXCLUSION CRITERIA\n\nPatients must not have physical or mental conditions that may make them unable to comply.\n\nSubjects may continue their other long-term medications with the exception of tricyclic antidepressants and anti-cholinergics, which may affect salivary gland function.\n\nPatients cannot take experimental drugs during the duration of the protocol.\n\nChildren will be excluded due to additional risks that may occur with etanercept."}, "identificationModule"=>{"nctId"=>"NCT00001954", "briefTitle"=>"Etanercept Therapy for Sjogren's Syndrome", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Etanercept Therapy for Sjogren's Syndrome", "orgStudyIdInfo"=>{"id"=>"000026"}, "secondaryIdInfos"=>[{"id"=>"00-D-0026"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Etanercept", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Dental And Craniofacial Research (NIDCR)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Dental and Craniofacial Research (NIDCR)", "class"=>"NIH"}}}}