{ "FullStudy":{ "Rank":217778, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516957", "OrgStudyIdInfo":{ "OrgStudyId":"20101227" }, "Organization":{ "OrgFullName":"Amgen", "OrgClass":"INDUSTRY" }, "BriefTitle":"AMG 827 in Subjects With Psoriatic Arthritis", "OfficialTitle":"A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis." }, "StatusModule":{ "StatusVerifiedDate":"March 2016", "OverallStatus":"Terminated", "WhyStopped":"Sponsor decision", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"August 18, 2011", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"March 14, 2016", "DispFirstSubmitQCDate":"March 14, 2016", "DispFirstPostDateStruct":{ "DispFirstPostDate":"April 13, 2016", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 14, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 13, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Amgen", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Psoriatic Arthritis" ] }, "KeywordList":{ "Keyword":[ "Psoriatic Arthritis", "IL-17", "AMG 827", "AMG827", "Musculoskeletal Disease", "Spondylarthropathy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"168", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"AMG 827 SC 140 mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"140 mg AMG 827", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: AMG 827" ] } },{ "ArmGroupLabel":"Placebo SC", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"AMG 827 SC 280 mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"280 mg AMG 827", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: AMG 827" ] } },{ "ArmGroupLabel":"AMG 827 SC 210 mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"AMG 827 SC 210 mg", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: AMG 827" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"AMG 827", "InterventionDescription":"140 mg AMG 827 SC (subcutaneous)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AMG 827 SC 140 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Placebo SC (subcutaneous)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo SC" ] } },{ "InterventionType":"Drug", "InterventionName":"AMG 827", "InterventionDescription":"280 mg AMG 827 SC (subcutaneous)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AMG 827 SC 280 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"AMG 827", "InterventionDescription":"210 mg AMG 827 SC (subcutaneous)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AMG 827 SC 210 mg" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12", "PrimaryOutcomeTimeFrame":"Baseline to week 12" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 50 response at week 12", "SecondaryOutcomeTimeFrame":"Baseline to week 12" },{ "SecondaryOutcomeMeasure":"To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 70 response at Week 12", "SecondaryOutcomeTimeFrame":"Baseline to week 12" },{ "SecondaryOutcomeMeasure":"To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Clinical Disease Activity Index (CDAI) change from baseline at week 12", "SecondaryOutcomeTimeFrame":"Baseline to week 12" },{ "SecondaryOutcomeMeasure":"To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Disease Activity Score with a 28 joint count (DAS 28) change from baseline at week 12", "SecondaryOutcomeTimeFrame":"Baseline to week 12" },{ "SecondaryOutcomeMeasure":"To evaluate the safety of AMG 827 in psoriatic arthritis as measured by development of antibodies to AMG 827", "SecondaryOutcomeTimeFrame":"up to 5 years" },{ "SecondaryOutcomeMeasure":"To evaluate the safety of AMG 827 in psoriatic arthritis as measured by number of subjects with AE", "SecondaryOutcomeTimeFrame":"up to 5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months\nSubject has ≥ 3 tender and ≥ 3 swollen joints\n\nExclusion Criteria:\n\nSubject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)\nSignificant concurrent medical conditions\nPregnant or breast feeding\nSignificant Laboratory abnormalities\nUse of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days\nUse of anti-TNF therapy within 2 months\nUse of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months\nPrior use of rituximab\nPrior use of anti-IL-17 biologic therapy, including AMG 827", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"MD", "OverallOfficialAffiliation":"Amgen", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"Peoria", "LocationState":"Arizona", "LocationZip":"85381", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Scottsdale", "LocationState":"Arizona", "LocationZip":"85258", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Tucson", "LocationState":"Arizona", "LocationZip":"85711", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Hemet", "LocationState":"California", "LocationZip":"92543", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Huntington Beach", "LocationState":"California", "LocationZip":"92646", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"La Jolla", "LocationState":"California", "LocationZip":"92037", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Los Angeles", "LocationState":"California", "LocationZip":"90095", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Palm Desert", "LocationState":"California", "LocationZip":"92260", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Palo Alto", "LocationState":"California", "LocationZip":"94304", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Victorville", "LocationState":"California", "LocationZip":"92395", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Sarasota", "LocationState":"Florida", "LocationZip":"34239", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Boise", "LocationState":"Idaho", "LocationZip":"83702", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Lexington", "LocationState":"Kentucky", "LocationZip":"40504", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Baton Rouge", "LocationState":"Louisiana", "LocationZip":"70809", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Frederick", "LocationState":"Maryland", "LocationZip":"21702", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Grand Rapids", "LocationState":"Michigan", "LocationZip":"49546", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Lansing", "LocationState":"Michigan", "LocationZip":"48910", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Lebanon", "LocationState":"New Hampshire", "LocationZip":"03756", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Rochester", "LocationState":"New York", "LocationZip":"14642", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Portland", "LocationState":"Oregon", "LocationZip":"97239", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Duncansville", "LocationState":"Pennsylvania", "LocationZip":"16635", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98122", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Victoria", "LocationState":"British Columbia", "LocationZip":"V8P 5P6", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"Winnipeg", "LocationState":"Manitoba", "LocationZip":"R3A 1M3", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"St. John's", "LocationState":"Newfoundland and Labrador", "LocationZip":"A1A 5E8", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"St. John's", "LocationState":"Newfoundland and Labrador", "LocationZip":"A1C 5B8", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"Newmarket", "LocationState":"Ontario", "LocationZip":"L3Y 3R7", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"Ottawa", "LocationState":"Ontario", "LocationZip":"K1H 8L6", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"QC", "LocationState":"Quebec", "LocationZip":"G1W 4R4", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"Trois-Rivieres", "LocationState":"Quebec", "LocationZip":"G8Z 1Y2", "LocationCountry":"Canada" },{ "LocationFacility":"Research Site", "LocationCity":"Quebec", "LocationZip":"G1V 3M7", "LocationCountry":"Canada" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"24918373", "ReferenceType":"background", "ReferenceCitation":"Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, Newmark R, Feng J, Erondu N, Nirula A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014 Jun 12;370(24):2295-306. doi: 10.1056/NEJMoa1315231." },{ "ReferencePMID":"26773108", "ReferenceType":"derived", "ReferenceCitation":"Mease PJ, Genovese MC, Mutebi A, Viswanathan HN, Chau D, Feng J, Erondu N, Nirula A. Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis. J Rheumatol. 2016 Feb;43(2):343-9. doi: 10.3899/jrheum.150182. Epub 2016 Jan 15." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"AmgenTrials clinical trials website", "SeeAlsoLinkURL":"http://www.amgentrials.com" } ] } } }, "ResultsSection":{ "MoreInfoModule":{} }, "AnnotationSection":{ "AnnotationModule":{ "UnpostedAnnotation":{ "UnpostedResponsibleParty":"Bausch Health Americas, Inc.", "UnpostedEventList":{ "UnpostedEvent":[ { "UnpostedEventType":"Release", "UnpostedEventDate":"November 8, 2016" },{ "UnpostedEventType":"Reset", "UnpostedEventDate":"January 6, 2017" },{ "UnpostedEventType":"Release", "UnpostedEventDate":"February 22, 2017" },{ "UnpostedEventType":"Reset", "UnpostedEventDate":"April 6, 2017" } ] } } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000571216", "InterventionMeshTerm":"Brodalumab" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000003879", "InterventionAncestorTerm":"Dermatologic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M259696", "InterventionBrowseLeafName":"Brodalumab", "InterventionBrowseLeafAsFound":"AMG 827", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M5657", "InterventionBrowseLeafName":"Dermatologic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001168", "ConditionMeshTerm":"Arthritis" },{ "ConditionMeshId":"D000015535", "ConditionMeshTerm":"Arthritis, Psoriatic" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007592", "ConditionAncestorTerm":"Joint Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" },{ "ConditionAncestorId":"D000025242", "ConditionAncestorTerm":"Spondylarthropathies" },{ "ConditionAncestorId":"D000025241", "ConditionAncestorTerm":"Spondylarthritis" },{ "ConditionAncestorId":"D000013166", "ConditionAncestorTerm":"Spondylitis" },{ "ConditionAncestorId":"D000013122", "ConditionAncestorTerm":"Spinal Diseases" },{ "ConditionAncestorId":"D000001847", "ConditionAncestorTerm":"Bone Diseases" },{ "ConditionAncestorId":"D000011565", "ConditionAncestorTerm":"Psoriasis" },{ "ConditionAncestorId":"D000017444", "ConditionAncestorTerm":"Skin Diseases, Papulosquamous" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3057", "ConditionBrowseLeafName":"Arthritis", "ConditionBrowseLeafAsFound":"Arthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16761", "ConditionBrowseLeafName":"Arthritis, Psoriatic", "ConditionBrowseLeafAsFound":"Psoriatic Arthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M21620", "ConditionBrowseLeafName":"Spondylarthropathies", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9204", "ConditionBrowseLeafName":"Joint Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21619", "ConditionBrowseLeafName":"Spondylarthritis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14544", "ConditionBrowseLeafName":"Spondylitis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14502", "ConditionBrowseLeafName":"Spinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3708", "ConditionBrowseLeafName":"Bone Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13005", "ConditionBrowseLeafName":"Psoriasis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18296", "ConditionBrowseLeafName":"Skin Diseases, Papulosquamous", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5437", "ConditionBrowseLeafName":"Spondylarthropathy", "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":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }