Nctid:
NCT00000401
Payload:
{"FullStudy"=>{"Rank"=>498925, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "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"=>"M4476", "ConditionBrowseLeafName"=>"Arthritis", "ConditionBrowseLeafAsFound"=>"Arthritis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4480", "ConditionBrowseLeafName"=>"Arthritis, Rheumatoid", "ConditionBrowseLeafAsFound"=>"Rheumatoid Arthritis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10621", "ConditionBrowseLeafName"=>"Joint Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12097", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15045", "ConditionBrowseLeafName"=>"Rheumatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6323", "ConditionBrowseLeafName"=>"Collagen Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6464", "ConditionBrowseLeafName"=>"Connective Tissue Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4629", "ConditionBrowseLeafName"=>"Autoimmune Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10200", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"110"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"July 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"Yes"}, "StatusVerifiedDate"=>"May 2013", "CompletionDateStruct"=>{"CompletionDate"=>"August 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"May 28, 2013", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 29, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"August 2005", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Repeated measures analysis of variance with contrasts to determine if the change in the PBMC-IFN gamma-alpha 1(II)/PBS stimulation index is significantly at the 0.05 level and/or greater than or equal to 30%.", "PrimaryOutcomeTimeFrame"=>"Before and after each 10-week treatment"}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"A Pearson correlation coefficient will be calculated for the change in the PBMC-INF gamma-alpha1(II)/PBS stimulation index and the change in the reactivity to RA CII epitope alpha 1 (II) CB11 for each dose.", "SecondaryOutcomeTimeFrame"=>"Before and after each 10-week treatment"}]}}, "OversightModule"=>{"OversightHasDMC"=>"Yes"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["NSAIDs", "Oral Tolerance", "Drug Interaction", "Oral Administration", "Interleukin 10", "Collagen", "Chemotherapy", "Human Therapy Evaluation", "DMARDs", "RA", "IL-10"]}, "ConditionList"=>{"Condition"=>["Rheumatoid Arthritis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"11177772", "ReferenceType"=>"background", "ReferenceCitation"=>"Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z."}, {"ReferencePMID"=>"15334493", "ReferenceType"=>"result", "ReferenceCitation"=>"Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. doi: 10.1002/art.20361. No abstract available."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.", "DetailedDescription"=>"RA is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. The study will evaluate the effects of using oral bovine CII on RA patients by assessing the levels of inflammation markers such as interferon gamma (IFN-gamma), interleukin-10 (IL-10), and transforming growth factor beta (TGF-beta). This study is a multicenter clinical trial to be conducted at the University of Tennessee, Memphis (the lead center) and the West Tennessee Medical Specialty Clinic (a collaborating site).\n\nPatients enrolled will be allowed to continue a constant dose of disease-modifying anti-rheumatic drugs (DMARDs) and prednisone less than or equal to 7.5 mg/day. Patients will be randomly assigned to one of two groups. The low dose group will receive 30 mcg daily for 10 weeks, then 50 mcg daily for 10 weeks, followed by 70 mcg daily for 10 more weeks; the high dose group will receive 90 mcg daily for 10 weeks, then 100 mcg daily for 10 weeks, followed by 130 mcg daily for 10 more weeks. Blood will be collected at screening and at Weeks 10, 20, and 30. Blood will be analyzed for indicators of inflammation.\n\nNote: this trial is no longer being conducted as an intervention trial. Accrual has been discontinued, although patients previously enrolled are still being followed."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"80 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Note: accrual into this trial has been discontinued, but patients previously enrolled are still being followed.\n\nInclusion Criteria:\n\nClinically stable RA and unlikely to require adjustment of doses of DMARDs, NSAIDs, prednisone, or anti-TNFα therapies for the treatment phase of the study\nMeets American College of Rheumatology (ACR) 1988 revised criteria for RA\nOnset of disease at age 16 or older\nOnset of disease at least 3 months prior to enrollment\nPBMC - IFNγ - α1(II)/PBS stimulation index greater than or equal to 1.5 in 6 months prior to baseline visit\nAgree to discontinue herbal remedies described in this protocol\nAgree to use acceptable forms of contraception\n\nExclusion Criteria:\n\nParticipation in another clinical research study involving the evaluation of another investigational drug within 90 days prior to study entry\nCurrently taking greater than 7.5 mg prednisone daily\nIntra-articular corticosteroid injections within 30 days prior to study entry\nConcurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study\nPregnancy\nBeef allergy\nUse of fish oil within 4 weeks of study entry\nPrevious use of auranofin or cyclophosphamide (all other DMARDs are allowed)\nPrevious autologous or heterologous stem cell transplantation\nActive malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation\nIntolerance to citrus juices or colorless carbonated beverages"}, "IdentificationModule"=>{"NCTId"=>"NCT00000401", "BriefTitle"=>"Oral Collagen for Rheumatoid Arthritis", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Tennessee"}, "OfficialTitle"=>"Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis", "OrgStudyIdInfo"=>{"OrgStudyId"=>"R01AR045255", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/R01AR045255", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01AR045255", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01AR045255", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"NIAMS-037"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"The low dose group will receive CII 30 mcg daily for 10 weeks, then 50 mcg daily for 10 weeks, followed by 70 mcg daily for 10 more weeks.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Oral bovine type II collagen"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"2", "ArmGroupDescription"=>"The high dose group will receive CII 90 mcg daily for 10 weeks, then 100 mcg daily for 10 weeks, followed by 130 mcg daily for 10 more weeks.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Oral bovine type II collagen"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Oral bovine type II collagen", "InterventionType"=>"Drug", "InterventionDescription"=>"Drug can be interrupted or stopped for suspected adverse events.", "InterventionOtherNameList"=>{"InterventionOtherName"=>["CII"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1", "2"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"38301", "LocationCity"=>"Jackson", "LocationState"=>"Tennessee", "LocationCountry"=>"United States", "LocationFacility"=>"The Arthritis Clinic of Jackson, PLLC"}, {"LocationZip"=>"38163", "LocationCity"=>"Memphis", "LocationState"=>"Tennessee", "LocationCountry"=>"United States", "LocationFacility"=>"University of Tennessee, Memphis"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Arnold E. Postlethwaite, MD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Tennessee at Memphis Department of Medicine"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of Tennessee", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyOldNameTitle"=>"Arnold E. Postlethwaite, MD", "ResponsiblePartyOldOrganization"=>"University of TN Health Science Center"}}}}}}
