{
  "FullStudy":{
    "Rank":217727,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517620",
          "OrgStudyIdInfo":{
            "OrgStudyId":"[2011]2-38"
          },
          "Organization":{
            "OrgFullName":"Sun Yat-sen University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 15, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 12, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 13, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Gu Jieruo",
            "ResponsiblePartyInvestigatorTitle":"Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University",
            "ResponsiblePartyInvestigatorAffiliation":"Sun Yat-sen University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Sun Yat-sen University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Ankylosing Spondylitis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"38",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Total Glucosides Paeony, Capsules",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Total Glucosides Paeony Capsules"
                  ]
                }
              },{
                "ArmGroupLabel":"no intervention",
                "ArmGroupType":"No Intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Total Glucosides Paeony Capsules",
                "InterventionDescription":"Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Total Glucosides Paeony, Capsules"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"the proportion of patients which disease activity reaches relapse criteria",
                "PrimaryOutcomeTimeFrame":"24 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"BASDAI score comparing to baseline",
                "SecondaryOutcomeTimeFrame":"24 weeks"
              },{
                "SecondaryOutcomeMeasure":"BASFI score comparing to baseline",
                "SecondaryOutcomeTimeFrame":"24 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAged from 16-65 years, sign the Informed Consent\nFulfill 1984 modified NewYork classification criteria for AS\nAchieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy\nHb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)\nCommitment to contraceptive for woman\n\nExclusion Criteria:\n\nHistory of psoriasis and/or inflammatory bowel diseases\nReceive intra-articular injection of cortisone within 3 months before enrollment\nHistory of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis\nPregnant and lactating women\nMentally ill, Alcoholics and drug addicts",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"16 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University",
                "LocationCity":"Guangzhou",
                "LocationState":"Guangdong",
                "LocationZip":"510630",
                "LocationCountry":"China"
              },{
                "LocationFacility":"Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University",
                "LocationCity":"Guangzhou",
                "LocationCountry":"China"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013166",
                "ConditionMeshTerm":"Spondylitis"
              },{
                "ConditionMeshId":"D000013167",
                "ConditionMeshTerm":"Spondylitis, Ankylosing"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001850",
                "ConditionAncestorTerm":"Bone Diseases, Infectious"
              },{
                "ConditionAncestorId":"D000007239",
                "ConditionAncestorTerm":"Infection"
              },{
                "ConditionAncestorId":"D000001847",
                "ConditionAncestorTerm":"Bone Diseases"
              },{
                "ConditionAncestorId":"D000009140",
                "ConditionAncestorTerm":"Musculoskeletal Diseases"
              },{
                "ConditionAncestorId":"D000013122",
                "ConditionAncestorTerm":"Spinal Diseases"
              },{
                "ConditionAncestorId":"D000025242",
                "ConditionAncestorTerm":"Spondylarthropathies"
              },{
                "ConditionAncestorId":"D000025241",
                "ConditionAncestorTerm":"Spondylarthritis"
              },{
                "ConditionAncestorId":"D000000844",
                "ConditionAncestorTerm":"Ankylosis"
              },{
                "ConditionAncestorId":"D000007592",
                "ConditionAncestorTerm":"Joint Diseases"
              },{
                "ConditionAncestorId":"D000001168",
                "ConditionAncestorTerm":"Arthritis"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14544",
                "ConditionBrowseLeafName":"Spondylitis",
                "ConditionBrowseLeafAsFound":"Spondylitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14545",
                "ConditionBrowseLeafName":"Spondylitis, Ankylosing",
                "ConditionBrowseLeafAsFound":"Ankylosing Spondylitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3708",
                "ConditionBrowseLeafName":"Bone Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3711",
                "ConditionBrowseLeafName":"Bone Diseases, Infectious",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10680",
                "ConditionBrowseLeafName":"Musculoskeletal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14502",
                "ConditionBrowseLeafName":"Spinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21620",
                "ConditionBrowseLeafName":"Spondylarthropathies",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21619",
                "ConditionBrowseLeafName":"Spondylarthritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2751",
                "ConditionBrowseLeafName":"Ankylosis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9204",
                "ConditionBrowseLeafName":"Joint Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3057",
                "ConditionBrowseLeafName":"Arthritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T5437",
                "ConditionBrowseLeafName":"Spondylarthropathy",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}