Nctid:
NCT00000433
Payload:
{"FullStudy"=>{"Rank"=>475175, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000013166", "ConditionMeshTerm"=>"Spondylitis"}, {"ConditionMeshId"=>"D000025241", "ConditionMeshTerm"=>"Spondylarthritis"}, {"ConditionMeshId"=>"D000013167", "ConditionMeshTerm"=>"Spondylitis, Ankylosing"}, {"ConditionMeshId"=>"D000009336", "ConditionMeshTerm"=>"Necrosis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000001850", "ConditionAncestorTerm"=>"Bone Diseases, Infectious"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000001847", "ConditionAncestorTerm"=>"Bone Diseases"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}, {"ConditionAncestorId"=>"D000013122", "ConditionAncestorTerm"=>"Spinal Diseases"}, {"ConditionAncestorId"=>"D000001168", "ConditionAncestorTerm"=>"Arthritis"}, {"ConditionAncestorId"=>"D000007592", "ConditionAncestorTerm"=>"Joint Diseases"}, {"ConditionAncestorId"=>"D000089183", "ConditionAncestorTerm"=>"Axial Spondyloarthritis"}, {"ConditionAncestorId"=>"D000025242", "ConditionAncestorTerm"=>"Spondylarthropathies"}, {"ConditionAncestorId"=>"D000000844", "ConditionAncestorTerm"=>"Ankylosis"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11974", "ConditionBrowseLeafName"=>"Necrosis", "ConditionBrowseLeafAsFound"=>"Necrosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15651", "ConditionBrowseLeafName"=>"Spondylitis", "ConditionBrowseLeafAsFound"=>"Spondylitis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M22725", "ConditionBrowseLeafName"=>"Spondylarthritis", "ConditionBrowseLeafAsFound"=>"Spondylitis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15652", "ConditionBrowseLeafName"=>"Spondylitis, Ankylosing", "ConditionBrowseLeafAsFound"=>"Spondylitis, Ankylosing", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4816", "ConditionBrowseLeafName"=>"Bone Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4819", "ConditionBrowseLeafName"=>"Bone Diseases, Infectious", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11787", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15609", "ConditionBrowseLeafName"=>"Spinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4166", "ConditionBrowseLeafName"=>"Arthritis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10311", "ConditionBrowseLeafName"=>"Joint Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2698", "ConditionBrowseLeafName"=>"Axial Spondyloarthritis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22726", "ConditionBrowseLeafName"=>"Spondylarthropathies", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3860", "ConditionBrowseLeafName"=>"Ankylosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5412", "ConditionBrowseLeafName"=>"Spondylarthropathy", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M311", "InterventionBrowseLeafName"=>"Etanercept", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Inflammatory Agents", "InterventionBrowseBranchAbbrev"=>"Infl"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Gastrointestinal Agents", "InterventionBrowseBranchAbbrev"=>"Gast"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"42"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"October 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"February 2003", "CompletionDateStruct"=>{"CompletionDate"=>"March 2002"}, "LastUpdateSubmitDate"=>"January 2, 2007", "StudyFirstSubmitDate"=>"January 18, 2000", "StudyFirstSubmitQCDate"=>"January 18, 2000", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 4, 2007", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"January 19, 2000", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Spondylitis", "Etanercept", "ENBREL", "Tumor necrosis factor-alpha"]}, "ConditionList"=>{"Condition"=>["Spondylitis, Ankylosing"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"11986408", "ReferenceType"=>"background", "ReferenceCitation"=>"Gorman JD, Sack KE, Davis JC Jr. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med. 2002 May 2;346(18):1349-56. doi: 10.1056/NEJMoa012664."}, {"ReferencePMID"=>"14613288", "ReferenceType"=>"background", "ReferenceCitation"=>"Davis JC Jr, Van Der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, Kivitz A, Fleischmann R, Inman R, Tsuji W; Enbrel Ankylosing Spondylitis Study Group. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum. 2003 Nov;48(11):3230-6. doi: 10.1002/art.11325."}, {"ReferencePMID"=>"12951863", "ReferenceType"=>"background", "ReferenceCitation"=>"Davis JC Jr, Huang F, Maksymowych W. New therapies for ankylosing spondylitis: etanercept, thalidomide, and pamidronate. Rheum Dis Clin North Am. 2003 Aug;29(3):481-94, viii. doi: 10.1016/s0889-857x(03)00028-0."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The Division of Rheumatology at University of California San Francisco is conducting a research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin. It blocks the action of tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid arthritis, and other inflammatory conditions. We will randomly assign patients to receive either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.", "DetailedDescription"=>"In this Phase II clinical trial we will use tumor necrosis factor receptor p75 fusion protein (TNFR:Fc, or etanercept) to treat patients with ankylosing spondylitis (AS). TNFR:Fc is an antagonist of tumor necrosis factor (TNF), a cytokine that researchers have shown to play a possible role in disease pathogenesis of ankylosing spondylitis, rheumatoid arthritis, and vasculitis, as well as other inflammatory conditions.\n\nTNFR:Fc consists of two molecules of the extracellular portion of the p75 receptor, each consisting of 235 amino acids. The two receptors are fused to the Fc portion of human IgG1, which consists of 232 amino acids. The gene fragments encoding the truncated TNFR and the Fc portion of human IgG1 are expressed in a Chinese hamster ovary cell line.\n\nRecent observations from animal and human studies suggest that tumor necrosis factor-alpha (TNF-alpha) may play a role in disease activity in AS and other seronegative spondyloarthropathies. This study aims to test the efficacy of TNFR:Fc used in conjunction with standard medications in the treatment of AS. We will give patients either 25mg of TNFR:Fc or placebo subcutaneously twice a week for 4 months. Outcome measures will include measures of function, pain, morning stiffness, patient global assessment, and swollen joint count, as well as safety measures."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"80 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nDiagnosis of Ankylosing spondylitis\nAcceptable stable treatments during study: oral glucocorticoids (less than or equal to 10 mg/d) and/or NSAIDs at recommended doses and/or one of the following options: methotrexate (less than or equal to 20.0 mg/week); sulfasalazine (less than or equal to 3 grams/d); azathioprine (less than or equal to 2 mg/kg/d); methotrexate and sulfasalazine combination at doses listed above; 6-mercaptopurine (less than or equal to 1.5 mg/kg/d)\n\nExclusion Criteria:\n\nDiagnosis of psoriatic arthritis, inflammatory bowel disease, reactive arthritis, or Behýet disease\nSignificant medical problems, such as diabetes mellitus\nHistory of active or recurrent infections\nComplete ankylosis of the entire spine"}, "IdentificationModule"=>{"NCTId"=>"NCT00000433", "BriefTitle"=>"Blocking Tumor Necrosis Factor in Ankylosing Spondylitis", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)"}, "OfficialTitle"=>"Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis", "OrgStudyIdInfo"=>{"OrgStudyId"=>"N01 AR92244"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"NIAMS-043"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Anti-Tumor Necrosis Factor", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"94143-0792", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCSF-Clinical Trials Center"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"John C. Davis, MD, MPH", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Division of Rheumatology, University of California - San Francisco Department of Medicine"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "LeadSponsorClass"=>"NIH"}}}}}}
