Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413361
Status:
COMPLETED
Last Update Posted:
2011-01-27
First Post:
2006-12-18
Brief Title:
The Reduction of Systemic Lupus Erythematosus Flares Study PLUS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official 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 Study
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ngml
Detailed 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 ngml
The 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 variability
To study the relation between blood HCQ concentrations SLE activity and quality of life
To study the relation between blood HCQ concentrations SLE activity and lipid profile of the patients
To study the relation between ECG abnormalities and blood HCQ concentrations
To constitute a bank of serum a DNAbank and a RNAbank to permit subsequent studies
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 ngml
The 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 variability
To study the relation between blood HCQ concentrations SLE activity and quality of life
To study the relation between blood HCQ concentrations SLE activity and lipid profile of the patients
To study the relation between ECG abnormalities and blood HCQ concentrations
To constitute a bank of serum a DNAbank and a RNAbank to permit subsequent studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None