{ "FullStudy":{ "Rank":218233, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511003", "OrgStudyIdInfo":{ "OrgStudyId":"PRGRA-10-04-KOR" }, "Organization":{ "OrgFullName":"Astellas Pharma Inc", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)", "OfficialTitle":"An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs", "Acronym":"TREASURE" }, "StatusModule":{ "StatusVerifiedDate":"August 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 5, 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 11, 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 11, 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 4, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 10, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 13, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Astellas Pharma Inc", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Astellas Pharma Korea, Inc.", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Rheumatoid Arthritis" ] }, "KeywordList":{ "Keyword":[ "calcineurin inhibitor", "Prograf", "Rheumatoid arthritis (RA)", "Tacrolimus" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"128", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Tacrolimus group", "ArmGroupType":"Experimental", "ArmGroupDescription":"oral", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tacrolimus" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Tacrolimus", "InterventionDescription":"oral", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Tacrolimus group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Prograf" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"ACR20 response rate 6 months post dose", "PrimaryOutcomeDescription":"ACR20 is 20% improvement in ACR (American College of Rheumatology) core set", "PrimaryOutcomeTimeFrame":"Baseline and 6 months post dose" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"ACR50 response rates at month 6", "SecondaryOutcomeDescription":"ACR50 is 50% improvement in ACR (American College of Rheumatology) core set", "SecondaryOutcomeTimeFrame":"Baseline and at month 6" },{ "SecondaryOutcomeMeasure":"ACR70 response rates at month 6", "SecondaryOutcomeDescription":"ACR70 is 70% improvement in ACR (American College of Rheumatology) core set", "SecondaryOutcomeTimeFrame":"Baseline and at month 6" },{ "SecondaryOutcomeMeasure":"Change in DAS28 from baseline to 6 months", "SecondaryOutcomeDescription":"DAS (Disease Activity Score in Rheumatoid Arthritis)", "SecondaryOutcomeTimeFrame":"Baseline and at month 6" },{ "SecondaryOutcomeMeasure":"Change in bone loss rate from baseline to 6 months", "SecondaryOutcomeDescription":"comparative factors for bone loss rate: bone mineral densitometry [BMD], bone turnover marker test", "SecondaryOutcomeTimeFrame":"Baseline and at month 6" },{ "SecondaryOutcomeMeasure":"Safety assessed by the incidence of adverse events, vital signs and lab-tests", "SecondaryOutcomeTimeFrame":"For 6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria\nSubjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer\nSubjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL\nSubjects with ≥ 3 swollen joints out of 66 joints assessed\nSubjects with ≥ 6 tender joints out of 68 joints assessed\n\nExclusion Criteria:\n\nPregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out\nSubjects with previous experience of tacrolimus (excluding external preparations)\nSubjects with renal dysfunction or with serum creatinin > 1.4 mg/dL at screening\nFollowing subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening\nSubjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c > 6.4% at screening\nSubjects complicated with hyperkalemia or with serum potassium level >5.5 mEq/L at screening\nSubjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications\nSubjects complicated with severe respiratory disease and infection\nSubjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.)\nSubjects who were treated with other investigational product(s) within 3 months before screening\nOther subjects who are considered ineligible for the study by the investigator", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Use Central Contact", "OverallOfficialAffiliation":"Astellas Pharma Inc", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Busan", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Daejeon", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Gyeonggi-do", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationCountry":"Korea, Republic of" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Link to results on Astellas Clinical Study Results website", "SeeAlsoLinkURL":"https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=151" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000016559", "InterventionMeshTerm":"Tacrolimus" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007166", "InterventionAncestorTerm":"Immunosuppressive Agents" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000065095", "InterventionAncestorTerm":"Calcineurin Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M17533", "InterventionBrowseLeafName":"Tacrolimus", "InterventionBrowseLeafAsFound":"Tacrolimus", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8795", "InterventionBrowseLeafName":"Immunosuppressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29039", "InterventionBrowseLeafName":"Calcineurin Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001168", "ConditionMeshTerm":"Arthritis" },{ "ConditionMeshId":"D000001172", "ConditionMeshTerm":"Arthritis, Rheumatoid" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007592", "ConditionAncestorTerm":"Joint Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" },{ "ConditionAncestorId":"D000012216", "ConditionAncestorTerm":"Rheumatic Diseases" },{ "ConditionAncestorId":"D000003240", "ConditionAncestorTerm":"Connective Tissue Diseases" },{ "ConditionAncestorId":"D000001327", "ConditionAncestorTerm":"Autoimmune Diseases" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3057", "ConditionBrowseLeafName":"Arthritis", "ConditionBrowseLeafAsFound":"Arthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3061", "ConditionBrowseLeafName":"Arthritis, Rheumatoid", "ConditionBrowseLeafAsFound":"Rheumatoid Arthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9204", "ConditionBrowseLeafName":"Joint Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13628", "ConditionBrowseLeafName":"Rheumatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4906", "ConditionBrowseLeafName":"Collagen Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5047", "ConditionBrowseLeafName":"Connective Tissue Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3210", "ConditionBrowseLeafName":"Autoimmune Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" } ] } } } } } }