4 Study 1 of 3 for search of: lupus hydroxychloroquine Home Search Study Topics Glossary Study 1 of 3 for search of: lupus hydroxychloroquineReturn to Search ResultsNext Study Full Text View Tabular View Contacts and Locations No Study Results Posted Related Studies The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS This study is currently recruiting participants. Verified by Assistance Publique - Hôpitaux de Paris, May 2007Sponsors and Collaborators:Assistance Publique - Hôpitaux de Paris Sanofi-SynthelaboInformation provided by:Assistance Publique - Hôpitaux de ParisClinicalTrials.gov Identifier:NCT PurposeThe main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/mlConditionInterventionPhaseSystemic Lupus ErythematosusDrug: versus hydroxychloroquinePhase IVMedlinePlusrelated topics: LupusDrug Informationavailable for: Hydroxychloroquine Hydroxychloroquine sulfate U.S. FDA ResourcesStudy Type: InterventionalStudy Design: Prevention, Randomized, Double Blind (Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy StudyOfficial Title: Study of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-Blood Concentration. National Multicenter Randomized Prospective StudyFurther study details as provided by Assistance Publique - Hôpitaux de Paris:Primary Outcome Measures:The number of patient in each group who developed a flare (according to the SELENA-SLEDAI composite criteria) during the study period. [ Time Frame: 7 months of follow up ]Secondary Outcome Measures:The number of patients in each group who developed a flare during the study period. [ Time Frame: 7 months of follow up ]The total number of flares in each group [ Time Frame: 7 months of follow up ]the total dose of steroids in each group [ Time Frame: 7 months of follow up ]the area under the curve of SELENA SLEDAI in each group [ Time Frame: 7 months of follow up ]the mean change of the quality of life questionnaire SF-36 [ Time Frame: 7 months of follow up ]the mean change on the score of analogical visual scale in each group [ Time Frame: 7 months of follow up ]Treatment tolerance evaluation will include clinical, electrocardiographic and ophthalmologic screening. [ Time Frame: 7 months of follow up ]Estimated Enrollment: 800Study Start Date: June 2007Estimated Study Completion Date: February 2011ArmsAssigned InterventionsA: Placebo ComparatorplaceboDrug: versus hydroxychloroquineB: Experimentalversus hydroxychloroquineDetailed Description:Hydroxychloroquine (HCQ) is a treatment which allows preventing Systemic Lupus Erythematosus (SLE) exacerbations.HCQ can be measured in whole-blood by HPLC (High Performance Liquid Chromatography).Interindividual variability in blood HCQ concentrations is important and a correlation between HCQ level and clinical efficacy of HCQ has been demonstrated in SLE in a monocentric study of 143 unselected SLE patients.The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/mlThe secondary objectives are:To define biological and clinical hallmarks present at M1 (month 1) which are predictor of SLE exacerbations in the next 6 month,To establish the parameters of HCQ pharmacokinetic model, by a study of population, using a "Bayésienne" approach.To study the influence of allelic variants of drug carriers and other genes in the interindividual variability of blood HCQ concentrations.To study the influence of the compliance in the blood HCQ concentration variabilityTo study the relation between blood HCQ concentrations, SLE activity and quality of lifeTo study the relation between blood HCQ concentrations, SLE activity and lipid profile of the patientsTo study the relation between ECG abnormalities and blood HCQ concentrationsTo constitute a bank of serum, a DNAbank, and a RNAbank to permit subsequent studies EligibilityAges Eligible for Study: 18 Years and olderGenders Eligible for Study: BothAccepts Healthy Volunteers: NoCriteriaInclusion Criteria:Age of 18 and aboveDiagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) Classification Criteria.Treatment with HCQ for at least 6 months, without modification of HCQ dosage for 2 monthsStable dosage of HCQ from one day to another (200 g x 2/day or 400 mg once a day or 200 mg once a day)No increase in the steroids dosage during the 3 previous weeksSteroids dosage lower or equal to 0. 5 mg/kg/day of prednisone equivalentNo modifications of a possible immunosuppressor during the 2 previous monthsSELENA-SLEDAI < or = 12Signature of the consent of participationExclusion Criteria:Known retinopathy, present or passedSevere cataract obstructing the ophthalmologic monitoringMONOPHTALM patientsPast history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosageUse of nivaquine during the 3 previous monthsTreatment with biotherapy (for example Rituximab) during the 12 previous monthsCalculated clearance of creatinin lower than 60 ml/minChronic alcoholismLiver failureDesire of pregnancy in the next 7 monthsKnown non compliance, and risks of random follow-upAbsence of social security coverPeople profiting from a particular protection:Pregnant womenAge under 18Patient under supervision and TRUSTEESHIPPeople who are hospitalized without their consent and not protected by the lawPeople who are private of freedom.Criteria of inclusion at the visit of randomization (D0):All the patients responding to the next criterions can be randomized:Blood HCQ concentration ranging between 100 and 750 ng/ml at the time of the visit of preselection,No increase in the steroids dosage since last visitNo modifications of a possible immunosuppressor since last visitSELENA-SLEDAI < or = 12 Activity of the lupus remaining stable (no increase of more than 2 points of the SELENA-SLEDAI),Ophthalmologic examination in the 6 previous months with no contra-indication for the use of HCQ,Absences of conductive disorders on the ECGUse of an effective contraception,Negative Beta-HCG. Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT ContactsContact: Nathalie COSTEDOAT-CHALUMEAU, MD +33 (0) LocationsFranceChu Pitie Salpetriere Recruiting PARIS, France, 75013 Contact: Nathalie COSTEDOAT-CHALUMEAU, MD,PhD +33(0) Hopital la Pitié Salpétrière Assistance Publique Paris, France, 75013 Contact: Jean Charles PIETTE, MdPh Contact: Zahir AMOURA, MdPh Sub-Investigator: Philippe LECHAT, Md-Ph Sub-Investigator: Jean Sébastien HULOT, Md Sponsors and CollaboratorsAssistance Publique - Hôpitaux de ParisSanofi-SynthelaboInvestigatorsPrincipal Investigator: Nathalie COSTEDOAT-CHALUMEAU, MD, Assistance Publique - Hôpitaux de Paris More InformationStudy ID Numbers: P051070First Received: December 18, 2006Last Updated: September 7, 2007ClinicalTrials.gov Identifier: NCTHealth Authority: France: Ministry of HealthKeywords provided by Assistance Publique - Hôpitaux de Paris:Systemic Lupus Erythematosus Hydroxychloroquine Study placed in the following topic categories:Autoimmune DiseasesLupus Erythematosus, SystemicHydroxychloroquineConnective Tissue DiseasesAdditional relevant MeSH terms:Anti-Infective AgentsAntimalarialsAntiparasitic AgentsAntiprotozoal AgentsMolecular Mechanisms of Pharmacological ActionImmune System DiseasesTherapeutic UsesEnzyme InhibitorsAntirheumatic AgentsPharmacologic ActionsClinicalTrials.gov processed this record on November 16, 2008U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information ActLinks to all studies - primarily for crawlers
13 Etudes ancillairesDéfinir les marqueurs cliniques et biologiques, prédictifs de poussée lupique dans les 6 mois (score ?).Étudier la compliance.Interactions médicamenteuses (dont mopral… antiacides…inh enz…).Étudier l’influence de variants alléliques des transporteurs de médicaments (P-GP), des cytochromes expliquant les variations de [HCQ]Etude du bilan lipidique et glucidiqueEtudes descriptives : de la cohorte; des lupus gériatriques…
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