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1、ARTHRITISBiRHEUMATISMVol41,No2,FcbruarylY98,pp290-29729001998,AmericanCollegeofRheumdtologyTREATMENTOFRHEUMATOIDARTHRITISWITHORALTYPEI1COLLAGENResultsofaMulticenter,Double-Blind,Placebo-ControlledTrialMARTHAL.BARNETT,JOELM.KREMER,E.WILLIAMST.CLAIR,DANIEL0.CLEGG,DANIELFURST,MICHAELWEI
2、SMAN,MALCOLMJ.F.FLETCHER,SCOTTCHASAN-TABER,EDUARDOFINGER,ALEJANDROMORALES,CHRISTINEH.LE,andDAVIDE.TRENTHAMObjective.Oraladministrationofcartilage-utilizing3setsofcompositecriteria:thePauluscriteria,derivedtypeI1collagen(CII)hasbeenshowntoame-theAmericanCollegeofRheumatologycriteriafo
3、rlioratearthritisinanimalmodelsofjointinflammation,improvementinRA,andarequirementfor230%andpreliminarystudieshavesuggestedthatthisnovelreductioninbothswollenandtenderjointcounts.therapyisclinicallybeneficialandsafeinpatientswithResults.Eighty-threepercentofpatientscom-rheumatoidarth
4、ritis(RA).Thepresentstudywasun-pleted24weeksoftreatment.Numerictrendsinfavorofdertakentotestthesafetyandefficacyof4differentthe20&daytreatmentgroupwereseenwithall3dosagesoforallyadministeredCIIinpatientswithRA.cumulativecompositemeasures.However,astatisticallyMethods.Twohundredsevent
5、y-fourpatientswithsignificantincrease(P=0.035)inresponseratefortheactiveRAwereenrolledat6differentsitesandrandom-20pgldaygroupversusplacebowasdetectedusingonlyizedtoreceiveplaceboor1of4dosages(20,100,500,orthePauluscriteria.Thepresenceofserumantibodiesto2,500&day)oforalCIIfor24weeks.
6、Efficacypara-CIIatbaselinewassignificantlyassociatedwithanmeterswereassessedmonthly.Cumulativeresponseincreasedlikelihoodofrespondingtotreatment.Norates(percentageofpatientsmeetingthecriteriafortreatment-relatedadverseeventsweredetected.Theresponseatanytimeduringthestudy)wereanalyzed
7、efficacyseenwiththelowestdosageisconsistentwiththefindingsofanimalstudiesandwithknownmecha-SupportedinpartbyAutoImmuneInc.,bygrantsfromthenismsoforaltoleranceinwhichlowerdosesoforallyNIHtotheGeneralClinicalResearchCentersatBethIsraelHospitaladministeredautoantigenspreferentiallyinduc
8、edisease-(M0
